Biological interface system with thresholded configuration

ABSTRACT

A system and method for a biological interface system that processes multicellular signals of a patient and controls one or more devices is disclosed. The system includes a sensor that detects the multicellular signals and a processing unit for producing the control signal based on the multicellular signals. The system further includes an automated configuration routine that is used to set or modify the value of one or more system configuration parameters.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. §119(e)of U.S. Provisional Application No. 60/644,686, filed Jan. 18, 2005.This application relates to commonly assigned U.S. application Ser. No.11/320,709 of J. Christopher Flaherty et al., entitled “BIOLOGICALINTERFACE SYSTEM WITH AUTOMATED CONFIGURATION” and filed on the samedate as the present application. The complete subject matter of theabove-referenced applications is incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to medical devices and related methods.More particularly, various embodiments relate to biological interfacesystems that include one or more devices controlled by processedmulticellular signals of a patient. A processing unit produces a controlsignal based on multicellular signals received from a sensor consistingof multiple electrodes. More particularly, the system includes anautomated patient training routine that is used to configure the systemto optimize control of the devices.

DESCRIPTION OF RELATED ART

Biological interface devices, for example neural interface devices, arecurrently under development for numerous patient applications includingrestoration of lost function due to traumatic injury or neurologicaldisease. Sensors, such as electrode arrays, implanted in the higherbrain regions that control voluntary movement, can be activatedvoluntarily to generate electrical signals that can be processed by abiological interface device to create a thought invoked control signal.Such control signals can be used to control numerous devices includingcomputers and communication devices, external prostheses, such as anartificial arm or functional electrical stimulation of paralyzedmuscles, as well as robots and other remote control devices. Patientsafflicted with amyotrophic lateral sclerosis (Lou Gehrig's Disease),particularly those in advanced stages of the disease, would also beappropriate for receiving a neural interface device, even if just toimprove communication to the external world, including Internet access,and thus improve their quality of life.

Early attempts to utilize signals directly from neurons to control anexternal prosthesis encountered a number of technical difficulties. Theability to identify and obtain stable electrical signals of adequateamplitude was a major issue. Another problem that has been encounteredis caused by the changes that occur to the neural signals that occurover time, resulting in a degradation of system performance. Neuralinterface systems that utilize other neural information or other neuraldata, such as electrocorticogram (ECOG) signals, local field potentials(LFPs) and electroencephalogram (EEG) signals have similar issues tothose associated with individual neuron signals. Since all of thesesignals result from the activation of large groups of neurons, thespecificity and resolution of the control signal that can be obtained islimited. However, if these lower resolution signals could be properlyidentified and the system adapt to their changes over time, simplecontrol signals could be generated to control rudimentary devices orwork in conjunction with the higher power control signals processeddirectly from individual neurons.

Commercialization of these neural interfaces has been extremely limited,with the majority of advances made by universities in a preclinicalresearch setting. As the technologies advance and mature, the naturalprogression will be to more sophisticated human applications, such asthose types of devices regulated by various governmental regulatoryagencies including the Food and Drug Administration in the UnitedStates.

As sophisticated biological interface systems are approved by the FDAand become commercially available, these systems need to includenumerous safety features required for medical devices. It may also berequired that the systems have simplified configuration routines, suchas patient training routines, which have minimal requirements and assurereliable functionality. Convenience and flexibility to the patient,their caregivers and family members, may also be necessary. There istherefore a need for an improved biological interface system whichincludes an automated patient training routine that can be utilized by apatient without need for another person at his or her site.

SUMMARY OF THE INVENTION

According to one exemplary aspect of the invention, a biologicalinterface system is disclosed. The biological interface system collectsmulticellular signals emanating from one or more living cells of apatient and transmits processed signals to a controlled device. Thesystem includes a sensor for detecting multicellular signals, the sensorcomprising a plurality of electrodes. The electrodes are designed todetect the multicellular signals. A processing unit is designed toreceive the multicellular signals from the sensor and process themulticellular signals to produce the processed signals transmitted tothe controlled device. A visual display is included to provide visualimages to the patient. The system further comprises an integratedpatient routine, such as an integrated software module of the system,that is performed to generate one or more system configurationparameters or values, these parameters used by the processing unit toproduce the processed signals. The integrated patient routine provides avisual representation of a human figure to the patient on the visualdisplay. The visual representation includes multiple human bodymovements provided for the patient to imagine similar movements. Thesystem stores, such as in internal memory of one or more systemcomponents, a set of multicellular signals detected by the sensorsimultaneous with the patient imagining the movements.

The representation of the human figure may be a series of photographs ora continuous video of an actor performing one or more motions.Alternatively the human figure may be a series of artistic sketches thatare digitally scanned or captured, or a computer animated motion of asimulated human. In a preferred embodiment, multiple groups of series ofmotions, such as those representing left and right arm, elbow, wristand/or finger motion, and left and right leg, hip, knee, ankle and/ortoe motion, and an operator such as the patient or the patient'sclinician can choose the group to be provided to the patient in thepatient training routine. In a preferred embodiment, the body sidechosen is the dominant side for the patient, such as the dominant sideprior to an injury, and/or the body portion chosen corresponds to thelocation of the sensor, such as choosing left arm motions when a sensorhas been placed in the left arm area of the patient's motor cortex. Inanother preferred embodiment, other features can be adjusted such asgender and age. In yet another preferred embodiment, multiple forms offeedback are provided to the patient, such as audio feedback includingspoken words, and the language of the spoken words is adjustable by anoperator of the system.

In an embodiment, the patient training routine can be performed withoutthe need for an operator in addition to the patient. In anotherpreferred embodiment, a operator at a remote location is utilized tocomplete the patient training routine. The patient training routine maybe an embedded software routine located in a system at the patient site,or at a remote location. The patient training routine preferablycomprises a set of steps, such as a set of steps that advance astriggered by one or more events, such as the successful completion of atask, or an input signal from the patient such as a monitored biologicsignal or the activation of a patient switch such as a tongue switch. Inanother preferred embodiment, the series of steps self-adjusts or adaptsbased on one or more events such as a measure of patient performance.Each time the patient training routine is performed, a patient trainingevent, the system configuration parameters generated may be used tobuild a transfer function applied to the multicellular signals toproduce the processed signals.

According to another aspect of the invention, a system troubleshootingroutine is integrated into the biological interface system of thepresent invention. The system troubleshooting routine can be performedwhen unsatisfactory system performance is detected or otherwisesuspected, or may be performed as a diagnostic routine. The integratedsystem troubleshooting routine is performed to modify one or more systemconfiguration parameters to improve system performance. The systemtroubleshooting routine includes similar additions and modifications tothe patient training routine described hereabove, and similarly providesa visual representation of a human figure to the patient, and can beconducted with or without operators in addition to the patient, such asan operator at a location remote from the patient in communication withthe biological interface system via the internet utilizing a remoteaccess routine.

According to yet another aspect of the invention, a biological interfacesystem is disclosed. The biological interface system collectsmulticellular signals emanating from one or more living cells of apatient and transmits processed signals to a controlled device. Thesystem includes a sensor for detecting multicellular signals, the sensorcomprising a plurality of electrodes. The electrodes are designed todetect the multicellular signals. A processing unit is designed toreceive the multicellular signals from the sensor and process themulticellular signals to produce the processed signals transmitted tothe controlled device. The system further comprises an integratedpatient routine, such as an integrated software module of the system,that is performed to generate one or more system configurationparameters or values, these parameters used by the processing unit toproduce the processed signals. The patient training routine includes asystem configuration plan comprising a first configuration of steps tobe performed. The patient training routine includes means of collectingand analyzing a first set of patient data. The first set of data isanalyzed and produces one or more outputs of the analysis. The patienttraining routine further includes means of modifying the systemconfiguration plan, such as to improve the patient training routine insubsequent steps. The configuration plan is modified when the one ormore outputs of the analysis of the first set of patient data fallsbelow a success threshold value.

In some exemplary embodiments, the first set of patient data iscollected prior to the patient controlling the controlled device, or acontrolled device surrogate, such as a surrogate to be used insubsequent steps of the patient training routine. In another exemplaryembodiment, the first set of data does not include data of the patientcontrolling the controlled device or a controlled device surrogate. Thefirst set of data preferably includes multicellular data, such as neuraldata including neural firing rates or information regarding neuralfiring rates. In an alternative or additional embodiment, the first setof data includes other patient physiologic data such as data collectedwith an additional sensor of the system. This additional physiologicdata may include heart rate, blood pressure, respiration, blood glucose,and/or other physiologic information. In an embodiment, the first set ofdata is collected while the patient is provided a time varying stimulus,such as a representation of a human figure including multiple bodymovements, a different moving visual stimulus on a display screen, or amoving object such as a robotic arm or the patient's own limb beingcontrolled, such as via FES or an exoskeleton, by a signal created by asystem component.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various embodiments of thepresent invention, and, together with the description, serve to explainthe principles of the invention. In the drawings:

FIG. 1 illustrates an exemplary embodiment of a biological interfacesystem consistent with the present invention wherein a wheelchair boundpatient conducts a patient training routine without need for anotheroperator;

FIG. 1 a illustrates a patient training visual display of the system ofFIG. 1, consistent with the present invention.

FIG. 2 illustrates an exemplary embodiment of a portion of thebiological interface system consistent with the present inventionwherein sensor electrodes are implanted in the brain of a patient and aportion of a processing unit is implanted on the skull of the patient;

FIG. 3 illustrates another exemplary embodiment of a biologicalinterface system consistent with the present invention wherein anoperator configures the system at the patient site;

FIG. 4 a illustrates a patient training display with a representation ofa human figure including an open fist time varying stimulus, consistentwith the present invention;

FIG. 4 b illustrates a patient training display with a representation ofa human figure including an open fist time varying stimulus, consistentwith the present invention;

FIG. 5 illustrates a biological interface system consistent with thepresent invention wherein the patient undergoes a patient trainingroutine while a remote operator assists in the procedure; and

FIG. 6 illustrates a patient training routine flow chart of an exemplaryembodiment of a biological interface system consistent with the presentinvention wherein a configuration plan may be improved prior torequiring the patient to control a device.

DESCRIPTION OF THE EMBODIMENTS

To facilitate an understanding of the invention, a number of terms aredefined immediately herebelow.

Definitions

As used herein, the term “biological interface system” refers to aneural interface system or any system that interfaces with living cellsthat produce electrical activity or cells that produce other types ofdetectable signals.

The term “cellular signals,” as used herein, refers to signals orcombination of signals that may emanate from any living cell, such as,for example, subcellular signals, intracellular signals, andextracellular signals. For example, “cellular signals” may include, butnot be limited to: neural signals (e.g., neuron action potentials orspikes, local field potential (LFP) signals, electroencephalogram (EEG)signals, electrocorticogram signals (ECoG), and signals whose frequencyrange falls between single neuron spikes and EEG signals); cardiacsignals (e.g., cardiac action potentials); electromyogram (EMG) signals;glial cell signals; stomach cell signals; kidney cell signals; livercell signals; pancreas cell signals; osteocyte cell signals; sensoryorgan cell signals (e.g., signals emanating from the eye or inner ear);tumor cell signals; and tooth cell signals.

The term “multicellular signals,” as used herein, refers to signalsemanating from two or more cells, or multiple signals emanating from asingle cell. The term “subcellular signals,” as used herein, refers to,for example, a signal derived from a part of a cell, a signal derivedfrom one particular physical location along or within a cell, a signalfrom a cell extension (e.g., dendrite, dendrite branch, dendrite tree,axon, axon tree, axon branch, pseudopod , or growth cone), and signalsfrom organelles (e.g., golgi apparatus or endoplasmic reticulum). Theterm “intracellular signals,” as used herein, refers to a signal that isgenerated within a cell or by the entire cell that is confined to theinside of the cell up to and including the membrane. The term“extracellular signals,” as used herein, refers to signals generated byone or more cells that occur outside of the cell(s).

As used herein, the term “patient” refers to any animal, such as amammal and preferably a human. Specific examples of a “patient” include,but are not limited to: individuals requiring medical assistance;healthy individuals; individuals with limited function; and individualswith lost motor or other function due to traumatic injury orneurological disease.

As used herein, the term “configuration” refers to any alteration,improvement, repair, calibration, or other system modifying eventwhether manual in nature or partially or fully automated. The term“configuration parameter,” as used herein, refers to a variable, or avalue of the variable, of a component, device, apparatus, and/or system.A configuration parameter has a value that can be: set or modified; usedto perform a function; used in a mathematical or other algorithm; usedas a threshold value to perform a comparison; and any combinationsthereof. A configuration parameter's value determines thecharacteristics or behavior of something. System configurationparameters are variables of the system of the present invention, such asthose used to by the processing unit to produce processed signals.

Other, numerous subsets of configuration parameters are applicable,these subsets including but not limited to: calibration parameters suchas a calibration frequency parameter; controlled device parameters suchas a time constant parameter; processing unit parameters such as a cellselection criteria parameter; patient parameters such as a patientphysiologic parameter such as heart rate; multicellular signal sensorparameters; other sensor parameters; system environment parameters;mathematical algorithm parameters; a safety parameter; and otherparameters. Certain parameters may be controlled by the patient'sclinician, such as a password-controlled parameter securely controlledby an integral permission routine of the system. Certain parameters mayrepresent a “threshold” such as a success threshold used in a comparisonto determine if the outcome of an event was successful. In numeroussteps of a system configuration or other function, a minimum performanceor other measure may be maintained by comparing a detected signal, orthe output of an analysis of one or more signals, to a successthreshold.

As used herein, the term “discrete component” refers to a component of asystem such as those defined by a housing or other enclosed or partiallyenclosed structure, or those defined as being detached or detachablefrom another discrete component. Each discrete component can transmitinformation to a separate component through the use of a physical cable,including one or more of electrically conductive wires or opticalfibers, or transmission of information can be accomplished wirelessly.Wireless communication can be accomplished with a transceiver that maytransmit and receive data such as through the use of “Bluetooth”technology or according to any other type of wireless communicationmeans, method, protocol or standard, including, for example, codedivision multiple access (CDMA), wireless application protocol (WAP),Infrared or other optical telemetry, radio frequency or otherelectromagnetic telemetry, ultrasonic telemetry or other telemetrictechnologies.

As used herein, the term “routine” refers to an established function,operation, or procedure of a system, such as an embedded software modulethat is performed or is available to be performed by the system.Routines may be activated manually such as by an operator of a system,or occur automatically such as a routine whose initiation is triggeredby another function, an elapsed time or time of day, or other trigger.The devices, apparatus, systems and methods of the present invention mayinclude or otherwise have integrated into one or their components,numerous types and forms of routines. An “adaptive processing routine”is activated to determine and/or cause a routine or other function to bemodified or otherwise adapt to maintain or improve performance. Acompetitive routine is activated to provide a competitive function forthe patient of the present invention to compete with, such as a functionwhich allows an operator of the system to compete with the patient in apatient training task; or an automated system function which controls avisual object which competes with a patient controlled object. A“configuration routine” is activated to configure one or more systemconfiguration parameters of the system, such as a parameter that needsan initial value assigned or a parameter that needs an existingparameter modified. A “language selection routine” is activated tochange a language displayed in text form on a display and/or in audibleform from a speaker. A “patient training routine” is activated to trainthe patient in the use of the system and/or train the system in thespecifics of the patient, such as the specifics of the patient'smulticellular signals that can be generated by the patient and detectedby the sensor. A “permission routine” is activated when a systemconfiguration or other parameter is to be initially set or modified in asecured manner. The permission routine may use one or more of: apassword; a restricted user logon function; a user ID; an electronickey; a electromechanical key; a mechanical key; a specific Internet IPaddress; and other means of confirming the identify of one or moreoperators prior to allowing a secure operation to occur. A “remotetechnician routine” is activated to allow an operator to access thesystem of the present invention, or an associated device, from alocation remote from the patient, or a system component to be modified.A “system configuration routine” is activated to configure the system,or one or more components or associated devices of the system. In asystem configuration routine, one or more system configurationparameters may be modified or initially set to a value. A “system resetroutine” is activated to reset the entire system or a system function.Resetting the system is sometimes required with computers and computerbased devices such as during a power failure or a system malfunction.

General Description of the Embodiments

Systems, methods, apparatus and devices consistent with the inventiondetect cellular signals generated within a patient's body and implementvarious signal processing techniques to generate processed signals fortransmission to one or more devices to be controlled. The systemincludes a sensor, comprising a plurality of electrodes that detectmulticellular signals from one or more living cells, such as from thecentral or peripheral nervous system of a patient. The system furtherincludes a processing unit that receives and processes the multicellularsignals and transmits a processed signal to a controlled device. Theprocessing unit utilizes various electronic, mathematic, neural net andother signal processing techniques in producing the processed signal.

An integrated patient training routine is embedded in one or morecomponents of the system. The patient training routine utilizes a visualdisplay of the system to provide a visual representation of a humanfigure to the patient. This visual representation includes multiplehuman body movements that are used by the patient to imagine variousmovements. The system stores a set of multicellular signals while thepatient imagines the movements, and uses the stored signals to generateone or more system configuration parameters, including parameter valuessuch as initial values and modified values. These configurationparameters are used to produce a transfer function that is applied tosubsequent multicellular signals to produce the processed signals usedto control one or more controllable devices. The patient trainingroutine may be a requirement of the system prior to allowing fullcontrol of the controlled device to the patient. The patient trainingroutine may adapt over time, such as to improve system performanceand/or reduce the patient requirements of the routine. The patienttraining routine may provide a system configuration plan, and theconfiguration plan may be adjusted based on the measurement of one ormore parameters that are collected prior to requiring the patient tocontrol a controlled device or a surrogate of a controlled device. Thepatient training routine may require no operator other than the patient,or may work with an operator at a remote location, such as a clinicalsite or a service group of the manufacturer of the biological interfacesystem.

The visual representation of the human figure may be picture based, suchas pictures from a video or digital camera of an actor providing thehuman movements, or may be a digital image or animation of one or moredrawing or computer generated human figure graphics. The human figuremay be adjustable, such as by the patient, these adjustments includingwhether the movements are accomplished by left or ride side body limbs,and which gender should be represented. Modifications such as these canbe accomplished with the use of a patient input device, such as a neckswitch or other input device. Additional feedback can be provided to thepatient, simultaneously or at a different time, such as audio feedbackprovided through one or more speakers. This audio feedback may includecombinations of tones or spoken language. The additional feedback isprovided to improve the quality of the system configuration parametersgenerated, to generate additional system configuration parameters,and/or provide an additional function. Other forms of feedback can beadditionally or alternatively provided to the patient, such as feedbackselected from the group of: visual; tactile; auditory; olfactory;gustatory; electrical stimulation such as cortical stimulation; andcombinations of the preceding. Additional visual feedback may include asecond visual representation of a human figure, provided simultaneouswith the first human figure or at different times.

Detailed Description of the Embodiments

Reference will now be made in detail to the present embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

Referring now to FIG. 1, an exemplary embodiment of the presentinvention is illustrated wherein a patient conducts a patient trainingroutine integral to a biological interface system wherein a visualrepresentation of a human figure is provided to the patient. Biologicalinterface system 100 includes this integral patient training routine,such as a software program or routine which is stored in volatile ornon-volatile memory of one or more system components, includingimplanted components. In an alternative embodiment, one or morecomponents of system 100 are at a site remote from the patient, such asa service bureau of the manufacturer, and the patient training routinesoftware module is completely or partially stored in this remote sitecomponent. The visual representation of the patient training routineprovides a series of movements for the patient to imagine, such as via aseries of pictures or a video of an actor demonstrating the movements.During the imagined movements, a set of multicellular signals receivedby the processing unit from the sensor are stored in system memory. Thepatient training routine is used to generate one or more systemconfiguration parameters, such as parameters that are used to generate atransfer function applied to multicellular signals to produce theprocessed signal. These system configuration parameters are preferablygenerated by performing an analysis of the stored multicellular signalsthat have been temporally correlated with the multiple human bodymovements provided by the patient training routine.

Patient 500 has been implanted with a sensor, not shown, such as one ormore groups of electrodes placed in the motor cortex of a patient. Thesesensor components are attached with wires or wire bundles to aprocessing unit, or processing units, also not shown but at least one ofwhich is fully implanted in the patient. The processing unit receivesmulticellular signals detected by the sensor electrodes and applies atransfer function to these signals to produce processed signals, whichare control signals used to control one or more controllable devices.The implanted processing unit, or processing unit portion, communicateswith a system component external to the patient via wirelesscommunication means such as infrared or radiofrequency (RF)transmissions. Patient 500 is depicted in wheelchair 310, which ispreferably a controlled device of biological interface system 100.Patient 500 has limited control of one or more legs, such as aparaplegic, and further may have limited use of one or more arms such asis often encountered in spinal cord injury and ALS patients.

Wheelchair 310 has mounted on an armrest selector module 400, which canbe used by an operator of the system, such as the patient, to select oneor more controlled devices to receive the processed signal. Selectormodule 400 preferably includes a touch screen display, this display alsoproviding the visual representation of the human figure to the patient.Referring additionally to FIG. 1 a, human FIG. 403 presents to patient500 the multiple human body movements used by patient 500 to imagine themovements that correspond with the set of multicellular signals storedin a memory component of the system. The patient training routine isconfigured to allow the patient to perform the routine without theassistance of a second operator of the system. In an alternativeembodiment, the patient routine utilizes a second operator, such as anoperator at the patient site, or at a location remote from the patientcommunicating with system 100 via the Internet.

The patient training routine includes a series of steps to be completed,including one or more discrete segments of human body movements providedon selector module 400. The steps of the routine advance upon an event,such as the completion of a task as detected by the system or based on apatient or other operator input. In order for the system to determine aspecific task has been successfully completed, an analysis of theperformance may be compared to a threshold value, such as a thresholdvalue that can be adjusted by an approved operator of the system such asthe patient's clinician. In a preferred embodiment, when an unsuccessfultask is determined, the specific step may be repeated, with or withoutmodification of the step, a different step performed, or othermodification. In another preferred embodiment, one or more sequences ofsteps advance based on a fixed time period expiring. If a stepprogresses due to a timeout, a modified sequence, such as a differentnext step may be implemented. Patient 500 is depicted with neck switch192, such that specific motions of patient 500's head will activate oneor more states of neck switch 192, these state changes provided viawireless communication means to one or more components of system 100.Additional or alternative patient input devices can be used, thesedevices selected from the group consisting of: chin joystick; eyebrowEMG switch such as an eyebrow EMG switch manufactured by Words+ Inc. ofLancaster, Calif.; EEG activated switch such as the switchedmanufactured by BrainFingers of Yellow Springs, Ohio, USA; eye trackersuch as the device manufactured by LC Technologies of Fairfax, Va., USA;a head tracker such as the device manufactured Synapse Adaptive of SanRafael, Calif., USA; neck movement switch; shoulder movement switch;sip-and-puff joystick controller such as the controller manufactured byQuadJoy of Sheboygan, Wis., USA; speech recognition switch; tongueswitch such as a tongue palate switch; and combinations of thepreceding. Other input devices, for the patient or a different operator,such as an operator at a location remote from the patient, may beincluded to provide input to the patient training program.

The patient training program may include one or more iterative loops ofsteps, such as: a repeating group of steps that are repeated for a fixednumber of cycles or fixed period of time; a group of steps that arerepeated until a performance level is achieved, such as a performancelevel which increases or decreases based on the performance level duringa prior group of steps that were completed; and/or steps repeated basedon an operator input parameter. These iterative loops of steps mayinclude multiple segments of multiple human body movements, wherein oneor more of these multiple segments may not be used in every patienttraining routine performed. Based on the number of iterative loops,operator input and/or patient 500 performance, the patient trainingroutine performed may be shorter or longer than the performance of thepatient training routine at a different time. In a preferred embodiment,the patient training routine is shorter in duration when performance isabove a threshold value, and longer in duration when performance isbelow a threshold value.

The patient training routine may include two discrete parts. Multiplesecond parts may be integral to the patient training routine softwaremodule, wherein a specific second part is chosen based on theperformance of patient 500 in the first part. Performance may includethe number of cells providing signals to the set of multicellularsignals received, the modulation rates or other modulation parameter ofone or more of these cellular signals, and/or other measurableparameter. The second part chosen may be determined in whole or in part,with a patient input signal, such as from one or more of the deviceslisted hereabove. In another preferred embodiment, the patient trainingroutine adapts, such as an automatic adaptation that occurs within asingle patient training event or between a first patient training eventand a second patient training event. The adaptation may include a changeto one or more parameters of the patient training routine, such as theset of multicellular signals processed to modify a system configurationparameter, a parameter determining which human body movements that areprovided to the patient, a configuration of additional feedback providedto the patient, and/or other parameter.

The system configuration parameter or parameters, including the initialand modified values of these parameters, which are generated by thepatient training routine, can be used by the system to perform one ormore functions, preferably used in a transfer function applied to themulticellular signals to produce the processed signals of system 100. Ina preferred embodiment, the parameters are selected from the groupconsisting of: selection of cells for processing; criteria for theselection of cells to be processed; a computational or other signalprocessing parameter; a signal transfer function parameter such as atransfer function coefficient for an algorithm, methodology ormathematical equation; a calibration routine parameter such ascalibration frequency; a controlled device parameter such as acontrolled device boundary limit such as a maximum velocity or maximumposition; and combinations of the preceding. In another preferredembodiment, the parameters are selected from the group consisting of:acceptable frequency range of cellular activity; cellular signalamplitude threshold value; selection of electrodes to include; selectionof cellular signals to include; type of frequency analysis such as powerspectral density; instruction information to patient such as imaginedmovement type or other imagined movement instruction; type, mode orconfiguration of feedback during provision of processed signal topatient; controlled device parameter such as controlled device mode;alarm or alert threshold value; success threshold value; andcombinations thereof.

When the patient training routine of system 100 has performed one ormore analyses to generate a system configuration parameter value orvalue modification, a permission routine of the system may be invokedprior to implementation or full implementation of the change. Thepermission routine may require confirmation of the new configurationparameter value by an operator, further including: a specific user ID orpassword; a specific IP address for a remote operator; a mechanical,electronic, or electromechanical key; and/or other confirming operatorrequirement. In another preferred embodiment, the patient confirms thenew configuration parameter value, such as via a chin joystick or otherpatient input device as has been listed hereabove.

In an alternative embodiment, the biological interface system of thepresent invention alternatively or additionally includes a systemtroubleshooting routine. The biological interface system collectsmulticellular signals emanating from one or more living cells of apatient and transmits processed signals to one or more controllabledevices. The system includes a sensor that detects the multicellularsignals and comprises a plurality of electrodes that detect themulticellular signals. The system also includes a processing unit thatreceives the multicellular signals from the sensor, processes themulticellular signals to produce processed signals, and transmits theprocessed signals to at least one controlled device. A systemtroubleshooting routine is integrated into one or more components of thebiological interface system, such as a software module integrated intovolatile or nonvolatile memory used by a microprocessor or othermicrocontroller based system. The software module may be integral to acomponent internal to the patient, or external to the patient such as ina component proximate the patient or at a site remote from the patient.An operator, such as the patient or a non-patient operator at a locationremote from the patient and accessing the system via a computer network,performs the system troubleshooting routine to improve systemperformance by modifying one or more system configuration parameters orparameter values. The processing unit uses these parameters to producethe processed signals transmitted to the controlled device. Prior tomodifying or setting a configuration parameter, a permission routine maybe invoked as has been described in detail hereabove in reference tochanging a parameter of the patient training routine. The integratedsystem troubleshooting routine provides a visual representation of ahuman figure to the patient. The visual representation preferablyincludes multiple human body movements, and can comprise visual imagesof a human actor, or can be an animated image such as a computeranimated human figure. The multiple human body movements may be providedas a time varying stimulus and used by the patient to imagine one ormore movements or other imagined states that are stored in systemmemory, and preferably temporally correlated to the visualrepresentation of the human figure.

The system troubleshooting routine of the present invention includes oneor more similar functions of the patient training routine described inreference to FIG. 1 hereabove. For example, the system troubleshootingroutine may incorporate audio feedback provided to the patient utilizinga speaker. The audio feedback may include spoken words, such as wordsprovided in a language adjustable by the patient or other operatorutilizing one or more input devices. Additional feedback can be providedto the patient, such as a second visual representation of a humanfigure, provided simultaneous with the first human figure or atdifferent times. Other feedback as described in reference to the patienttraining routine can be included such as feedback selected from thegroup consisting of: visual; tactile; auditory; olfactory; taste;electrical stimulation; and combinations thereof. The performance of thesystem troubleshooting routine preferably stores one or more sets ofdata.

The system troubleshooting routine preferably includes a set of steps,again similar to the patient training routine, the set of stepsincluding multiple discrete segments of feedback provided to thepatient, such as visual feedback including the visual representation ofa human figure. The steps can progress as described in reference to thepatient training routine steps, such as via a patient input device, acompleted or successfully completed patient task, or after an expiredduration of time. The steps may similarly include one or more iterativeloops, and the system trouble shooting routine includes a first partthat can progress to one or more second parts, such as multiple secondparts selected via a performance value from the first part. In apreferred embodiment, the system troubleshooting routine similarlyadapts, such as an adaptation within a single system troubleshootingroutine event, or from a first patient training routine event to asecond patient training routine event.

Referring now to FIG. 2, a brain implant apparatus consistent with anembodiment of the present invention is illustrated. As shown in FIG. 2,the system includes an array of electrodes assembly, sensor 200, whichhas been inserted into a brain 250 of patient 500, through a previouslycreated opening in scalp 270 and skull 260 in a surgical procedure knownas a craniotomy. Sensor 200 includes a plurality of longitudinalprojections 211 extending from a base, array substrate 210. Projections211 may be rigid, semi-flexible or flexible, the flexibility such thateach projection 211 can still penetrate into neural tissue, potentiallywith an assisting device or with projections that only temporarily existin a rigid condition. Sensor 200 has been inserted into brain 250,preferably using a rapid insertion tool, such that the projections 211pierce into brain 250 and sensor substrate 210 remains in closeproximity to or in light contact with the surface of brain 250. At theend of each projection 211 is an electrode, electrode 212. Inalternative embodiments, electrodes can be located at a location otherthan the tip of projections 211 or multiple electrodes may be includedalong the length of one or more of the projections 211. One or moreprojections 211 may be void of any electrode, such projectionspotentially including anchoring means such as bulbous tips or barbs, notshown.

Electrodes 212 are configured to detect electrical brain signals orimpulses, such as individual neuron spikes or signals that representclusters of neurons such as local field potential (LFP) andelectroencephalogram (EEG) signals. Each electrode 212 may be used toindividually detect the firing of multiple neurons, separated by neuronspike discrimination techniques. Other applicable signals includeelectrocorticogram (ECoG) signals and other signals, such as signalsbetween single neuron spikes and EEG signals. Sensor 200 may be placedin any location of a patient's brain allowing for electrodes 212 todetect these brain signals or impulses. In a preferred embodiment,electrodes 212 can be inserted into a part of brain 250 such as thecerebral cortex. Alternative forms of penetrating electrodes, such aswire or wire bundle electrodes, can make up or be a component of thesensor of the present invention. In addition to or alternative fromneural signals, the system of the present invention may utilize othertypes of cellular signals to produce processed signals to control adevice. The various forms of penetrating electrodes described above canbe placed into tissue within or outside of the patient's cranium, suchtissue including but not limited to: nerve tissue such as peripheralnerve tissue or nerves of the spine; organ tissue such as heart,pancreas, liver or kidney tissue; tumor tissue such as brain tumor orbreast tumor tissue; other tissue and combinations of the preceding,

Alternatively or additionally, the sensor of the present invention mayemploy non-penetrating electrode configurations, not shown, such assubdural grids placed inside the cranium such as to record LFP signals.In addition to subdural grids, the sensor may comprise other forms ofnon-penetrating electrodes such as flat electrodes, coil electrodes,cuff electrodes and skin electrodes such as scalp electrodes. Thesenon-penetrating electrode configurations are placed in, on, near orotherwise in proximity to the cells whose signals are to be detected,such as neural or other cellular signals. In another alternativeembodiment, the sensor of the present invention includes detectors otherthan electrodes, such as photodetectors that detect cellular signalsrepresented by a light emission. The light emission can be caused by aphotodiode, integrated into the sensor or other implanted ornon-implanted system component, shining one or more wavelengths of lighton the appropriate cells. In addition to the numerous types of cellsdescribed above, one or more of the various configurations of the sensorof the present invention may utilize any living cell of the body thatemanates cellular signals. In a preferred embodiment, the cellularsignals are under voluntary control of the patient.

Although FIG. 2 depicts sensor 200 as a single discrete component, inalternative embodiments the sensor comprises multiple discretecomponents, including one or more types of electrodes or other cellularsignal detecting elements, each configured and placed to detect similaror dissimilar types of cellular signals. Multiple sensor discretecomponents can be implanted entirely within: the skull, an extracraniallocation such as a peripheral nerve, or external to the body; or thecomponents can be placed in any combination of these locations.

Sensor 200 serves as the multicellular signal sensor of the biologicalinterface system of the present invention. While FIG. 2 shows sensor 200as eight projections 211 with eight electrodes 212, sensor 200 mayinclude one or more projections with and without electrodes, both theprojections and electrodes having a variety of sizes, lengths, shapes,surface areas, forms, and arrangements. Moreover, sensor 200 may be alinear array (e.g., a row of electrodes) or a two-dimensional array(e.g., a matrix of rows and columns of electrodes such as a ten by tenarray), or wire or wire bundle electrodes, all well known to those ofskill in the art. An individual wire lead may include a plurality ofelectrodes along its length. Projections and electrodes may have thesame materials of construction and geometry, or there may be variedmaterials and/or geometries used in one or more electrodes. Eachprojection 211 and electrode 212 of FIG. 2 extends into brain 250 todetect one or more cellular signals such as those generated form theneurons located in proximity to each electrode 212's placement withinthe brain. Neurons may generate such signals when, for example, thebrain instructs a particular limb to move in a particular way and/or thebrain is planning that movement. In a preferred embodiment, theelectrodes reside within the arm, hand, leg or foot portion of the motorcortex of the brain. The processing unit of the present invention mayassign one or more specific cellular signals to a specific use, such asa specific use correlated to a patient imagined event. In a preferredembodiment, the one or more cellular signals assigned to a specific useare under voluntary control of the patient.

Referring back to FIG. 2, the processing unit of the present inventionincludes processing unit first portion 130 a, placed under the scalp ata location near patient 500's ear 280. Processing unit first portion 130a receives cellular signals from sensor 200 via wire bundle 220, amulti-conductor cable. In a preferred embodiment, wire bundle 220includes a conductor for each electrode 212. Processed signals areproduced by processing unit first portion 130 a and other processingunit discrete components, such as processing unit second portion 130 bremovably placed on the external skin surface of patient 500 near ear280. Processing unit second portion 130 b remains in relative closeproximity to implanted component processing unit first portion 130 athrough one or more fixation means such as cooperative magnetic means inboth components, or body attachment means such as where the processingunit second portion 130 b is attached to eye glasses, an ear wrappingarm, a hat, mechanical straps or an adhesive pad. Processing unit firstportion 130 a and processing unit second portion 130 b work incombination to receive multicellular signal data and create a time codeof brain activity.

In the preferred embodiment depicted in FIG. 2, bone flap 261, theoriginal bone portion removed in the craniotomy, has been used to closethe hole made in the skull 260 during the craniotomy, obviating the needfor a prosthetic closure implant. Bone flap 261 is attached to skull 260with one or more straps, bands 263, which are preferably titanium orstainless steel. Band 263 is secured to bone flap 261 and skull 260 withbone screws 262. Wire bundle 220 passes between bone flap 261 and thehole cut into skull 260. During the surgical procedure, bone recess 265was made in skull 260 such that processing unit first portion 130 acould be placed in the indentation, allowing scalp 270 to lie relativelyflat and free of tension in the area proximal to processing unit firstportion 130 a. A long incision in scalp 270 between the craniotomy siteand the recess 265 can be made to place processing unit first portion130 a in recess 265. Alternatively, an incision can be made to performthe craniotomy, and a separate incision made to form recess 265, afterwhich the processing unit first portion 130 a and wire bundle 220 can betunneled under scalp 270 to the desired location. Processing unit firstportion 130 a is attached to skull 260 with one or more bone screws or abiocompatible adhesive, not shown.

In an alternative embodiment, processing unit first portion 130 a may beplaced entirely within skull 260 or be geometrically configured andsurgically placed to fill the craniotomy hole instead of bone flap 261.Processing unit first portion 130 a can be placed in close proximity tosensor 200, or a distance of 5-20 cm can separate the two components.Processing unit first portion 130 a includes a biocompatible housingwhich creates a fluid seal around wire bundle 220 and numerous internalcomponents of processing unit first portion 130 a, internal componentsnot shown. Processing unit first portion 130 a internal componentsprovide the following functions: signal processing of the cellularsignals received from sensor 200 such as buffering, amplification,digital conversion and multiplexing, wireless transmission of cellularsignals, a partially processed, or derivative form of the cellularsignals, or other data; inductive power receiving and conversion; andother functions well known to implanted electronic assemblies such asimplanted pacemakers, defibrillators and pumps.

Processing unit second portion 130 b, removably placed at a locationproximate to implanted processing unit first portion 130 a but externalto patient 500, receives data from processing unit first portion 130 avia wireless communication through the skin, such as infrared orradiofrequency wireless data transfer means. Processing unit secondportion 130 b, includes, in addition to wireless data receiving means,wireless power transfer means such as an RF coil which inductivelycouples to an implanted coil, signal processing circuitry, an embeddedpower supply such as a battery, and data transfer means. The datatransfer means of processing unit second portion 130 b may be wired orwireless, and transfer data to one or more of: implanted processing unitfirst portion 130 a; a different implanted device; and an externaldevice such as an additional component of the processing unit of thepresent invention, a controlled device of the present invention or acomputer device such as a configuration computer with Internet access,all not shown.

Referring back to FIG. 2, electrodes 212 transfer the detected cellularsignals to processing unit first portion 130 a via array wires 221 andwire bundle 220. Wire bundle 220 includes multiple conductive elements,and array wires 221, which preferably include a conductor for eachelectrode of sensor 200. Also included in wire bundle 220 are twoconductors, first reference wire 222 and second reference wire 223 eachof which is placed in an area in relative proximity to sensor 200 suchas on the surface of brain 250 near the insertion location. Firstreference wire 222 and second reference wire 223 may be redundant, andprovide reference signals used by one or more signal processing elementsof the processing unit of the present invention to process the cellularsignal data detected by one or more electrodes. In an alternativeembodiment, not shown, sensor 200 comprises multiple discrete componentsand multiple bundles of wires connect to one or more discrete componentsof the processing unit, such as processing unit first portion 130 a. Inanother alternative embodiment, not shown, cellular signals detected bysensor 200 are transmitted to processing unit 130 a via wirelesstechnologies, such as infrared communication incorporated into anelectronic module of sensor 200, such transmissions penetrating theskull of the patient, and obviating the need for wire bundle 220, arraywires 221 and any physical conduit passing through skull 260 after thesurgical implantation procedure is completed.

Processing unit first portion 130 a and processing unit second portion130 b independently or in combination preprocess the received cellularsignals (e.g., impedance matching, noise filtering, or amplifying),digitize them, and further process the cellular signals to extractneural data that processing unit second portion 130 b may then transmitto an external device (not shown), such as an additional processing unitcomponent and/or any device to be controlled by the processedmulticellular signals. For example, the external device may decode thereceived neural data into control signals for controlling a prostheticlimb or limb assist device or for controlling a computer cursor. In analternative embodiment, the external device may analyze the neural datafor a variety of other purposes. In another alternative embodiment, thedevice receiving transmissions from processing unit second portion 130 bis an implanted device. Processing unit first portion 130 a andprocessing unit second portion 130 b independently or in combinationinclude signal processing circuitry to perform multiple signalprocessing functions including but not limited to: amplification,filtering, sorting, conditioning, translating, interpreting, encoding,decoding, combining, extracting, sampling, multiplexing, analog todigital converting, digital to analog converting, mathematicallytransforming and/or otherwise processing cellular signals to generate acontrol signal for transmission to a controlled device. Processing unitfirst portion 130 a and processing unit second portion 130 b may includeone or more components to assist in processing the multicellular signalsor to perform additional functions. These components include but are notlimited to: a temperature sensor; a pressure sensor; a strain gauge; anaccelerometer; a volume sensor; an electrode; an array of electrodes; anaudio transducer; a mechanical vibrator; a drug delivery device; amagnetic field generator; a photo detector element; a camera or othervisualization apparatus; a wireless communication element; a lightproducing element; an electrical stimulator; a physiologic sensor; aheating element and a cooling element.

Processing unit first portion 130 a transmits raw or processed cellularsignal data to processing unit second portion 130 b through integratedwireless communication means, such as the infrared communication meansof FIG. 2, or alternative means including but not limited toradiofrequency communications, other optical communications, inductivecommunications, ultrasound communications and microwave communications.In a preferred, alternate embodiment, processing unit first portion 130a includes both infrared communication means for short-range high baudrate communication, and radiofrequency communication means for longerrange, lower baud rate communication. This wireless transfer allowssensor 200 and processing unit first portion 130 a to be completelyimplanted under the skin of the patient, avoiding the need for implanteddevices that require protrusion of a portion of the device or wiredconnections through the skin surface. In an alternative embodiment, athrough the skin pedestal connector is utilized between either theimplanted sensor 200 or processing unit first portion 130 a and anexternal component. Processing unit first portion 130 a includes a coil,not shown, which receives power through inductive coupling, on acontinual or intermittent basis from an external power transmittingdevice such as processing unit second portion 130 b. The inductivecoupling power transfer configuration obviates the need for anypermanent power supply, such as a battery, integral to processing unitfirst portion 130 a.

In addition to or in place of power transmission, the integrated coil ofprocessing unit first portion 130 a and its associated circuitry mayreceive data from an external coil whose signal is modulated incorrelation to a specific data signal. The power and data can bedelivered to processing unit first portion 130 a simultaneously such asthrough simple modulation schemes in the power transfer that are decodedinto data for processing unit first portion 130 a to use, store orfacilitate another function. A second data transfer means, in additionto a wireless means such as an infrared LED, can be accomplished bymodulating a signal in the coil of processing unit first portion 130 athat data is transmitted from the implant to an external deviceincluding a coil and decoding elements. In a preferred embodiment, theprocessing unit first portion 130 a included an embedded ID, which canbe wirelessly transmitted to the processing unit second portion 130 b ora separate discrete component via the various wireless transmissionmeans described above. In another preferred embodiment, processing unitsecond portion 130 b includes means of confirming proper ID fromprocessing unit first portion 130 a and processing unit second portion130 b also included an embedded ID.

Processing unit first portion 130 a and processing unit second portion130 b may independently or in combination also conduct adaptiveprocessing of the received cellular signals by changing one or moreparameters of the system to achieve acceptable or improved performance.Examples of adaptive processing include, but are not limited to,changing a system configuration parameter during a system configuration,changing a method of encoding neural or other cellular signal data,changing the type, subset, or amount of cellular signal data that isprocessed, or changing a method of decoding neural or other cellularsignal data. Changing an encoding method may include changing neuronspike sorting methodology, calculations, thresholds, or patternrecognition methodologies. Changing a decoding methodology may includechanging variables, coefficients, algorithms, and/or filter selections.Other examples of adaptive processing may include changing over time thetype or combination of types of signals processed, such as EEG, ECoG,LFP, neural spikes, or other cellular signal types.

Processing unit first portion 130 a and processing unit second portion130 b may independently or in combination also transmit electricalsignals to one or more electrodes 212 such as to stimulate, polarize,hyperpolarize or otherwise cause an effect on one or more cells ofneighboring tissue. Specific electrodes may record cellular signalsonly, or deliver energy only, and specific electrodes may provide bothfunctions. In an alternative embodiment, a separate device, not shownbut preferably an implanted device with the ability to independently orin combination provide an electrical signal to multiple electrodes,delivers stimulating energy to one or more electrodes 212 or differentelectrodes, also not shown. Stimulating electrodes in various locationscan transmit signals to the central nervous system, peripheral nervoussystem, other body systems, body organs, muscles and other tissue orcells. The transmission of these signals is used to perform one or morefunctions including but not limited to: pain therapy; musclestimulation; seizure disruption; stroke rehabilitation; coma recovery;and patient feedback.

In an alternative embodiment, not shown, processing unit first portion130 a, and potentially additional signal processing functions areintegrated into sensor 200, such as through the use of a bondedelectronic microchip. In another alternative embodiment, processing unitfirst portion 130 a may also receive non-neural cellular signals and/orother biologic signals, such as from an implanted sensor. These signalsmay be in addition to received neural multicellular signals, and theymay include but are not limited to: EKG signals, respiration signals,blood pressure signals, electromyographic activity signals and glucoselevel signals. Such biological signals may be used to change the stateof the biological interface system of the present invention, or one ofits discrete components. Such state changes include but are not limitedto: turn system or component on or off; to begin a configurationroutine; to initiate or conclude a step of a configuration or otherroutine; and to start or stop another system function. In anotheralternative embodiment, processing unit first portion 130 a andprocessing unit second portion 130 b independently or in combinationproduce one or more additional processed signals, to additionallycontrol the controlled device of the present invention or to control oneor more additional controlled devices.

In an alternative, preferred configuration of implanted components, notshown, a discrete component such as a sensor of the present invention isimplanted within the cranium of the patient, such as sensor 200 of FIG.2, a processing unit or a portion of a processing unit of the presentinvention is implanted in the torso of the patient, and one or morediscrete components are external to the body of the patient. Theprocessing unit may receive multicellular signals from the sensor viawired, including conductive wires and optic fibers, or wirelesscommunication. The sensor 200 preferably includes signal processingmeans including signal processing up to and including digitizing themulticellular signals. In another alternative embodiment, preferably anacute (less than 24 hours) or sub-chronic (less than 30 days)application, a through the skin, or transcutaneous device is used totransmit or enable the transmission of the multicellular signals, and/ora derivative or pre-processed form of the multicellular signals.

Referring now to FIG. 3, a biological interface system 100 is showncomprising implanted components, not shown, and components external tothe body of a patient 500. A sensor for detecting multicellular signals,not shown and preferably a two dimensional array of multiple protrudingelectrodes, has been implanted in the brain of patient 500, in an areasuch as the motor cortex. In a preferred embodiment, the sensor isplaced in an area to record multicellular signals that are undervoluntary control of the patient. Alternatively or additionally to thetwo dimensional array, the sensor may include one or more wires or wirebundles which include a plurality of electrodes. Patient 500 of FIG. 3is shown as a human being, but other mammals and life forms that producerecordable multicellular signals would also be applicable. Patient 500may be a patient with a spinal cord injury or afflicted with aneurological disease that has resulted in a loss of voluntary control ofvarious muscles within the patient's body. Alternatively oradditionally, patient 500 may have lost a limb, and system 100 willinclude a prosthetic limb as its controlled device. Numerous types ofpatients, including healthy individuals, are applicable to the system ofthe present invention. The patient of the present invention may be aquadriplegic, a paraplegic, an amputee, a spinal cord injury victim oran otherwise physically impaired person. Alternatively or in addition,Patient 500 may have been diagnosed with one or more of: obesity, aneating disorder, a neurological disorder, a psychiatric disorder, acardiovascular disorder, an endocrine disorder, sexual dysfunction,incontinence, a hearing disorder, a visual disorder, sleeping disorder,a movement disorder, a speech disorder, physical injury, migraineheadaches or chronic pain. System 100 can be used to treat one or moremedical conditions of patient 500, or to restore, partially restore,replace or partially replace a lost function of patient 500.

Alternatively, system 100 can be utilized by patient 500 to enhanceperformance, such as if patient 500 did not have a disease or conditionfrom which a therapy or restorative device could provide benefit, butdid have an occupation wherein thought control of a device provided anotherwise unachieved advancement in healthcare, crisis management andnational defense. Thought control of a device can be advantageous innumerous healthy individuals including but not limited to: a surgeon,such as an individual surgeon using thought control to maneuver three ormore robotic arms in a complex laparoscopic procedure or a surgeoncontrolling various instruments at a location remote from theinstruments and the surgical procedure; a crisis control expert, such asa person who in attempting to minimize death and injury uses thoughtcontrol to communicate different pieces of information and/or controlmultiple pieces of equipment, such as urban search and rescue equipment,simultaneously during an event such as an earthquake or other disaster,both natural disasters and those caused by man; a member of a bombsquad, such as an expert who uses thoughts to control multiple robotsand/or robotic arms to remotely diffuse a bomb; and military personnelwho use thought control to communicate with personnel and controlmultiple pieces of defense equipment, such as artillery, aircraft,watercraft, land vehicles and reconnaissance robots. It should be notedthat the above advantages of system 100 to a healthy individual are alsoadvantages achieved in a patient such as a quadriplegic or paraplegic.In other words, a quadriplegic could provide significant benefit tosociety, such as in controlling multiple bomb diffusing robots, inaddition to his or her ambulation and other quality of life devices.Patients undergoing implantation and use of the system 100 of thepresent invention may provide numerous occupational and other functionsnot available to individuals that do not have the biological interfacesystem of the present invention.

The sensor electrodes of system 100 can be used to detect variousmulticellular signals as has been described in detail in reference toFIG. 2 hereabove. The sensor is connected via a multi-conductor cable,not shown but also implanted in patient 500, to an implanted portion ofthe processing unit which includes some signal processing elements aswell as wireless communication means as has been described in detail inreference to FIG. 2. The implanted multi-conductor cable preferablyincludes a separate conductor for each electrode, as well as additionalconductors to serve other purposes, such as providing reference signalsand ground. A second portion of the processing unit, processing unitsecond portion 130 b receives the wireless communications from theimplanted portion. Processing unit second portion 130 b is removablylocated just above the ear of patient 500, such as to be aligned with aninfrared data transmission element of the implanted device.Multicellular signals or derivatives of the multicellular signals aretransmitted from the implanted processing unit component to processingunit second portion 130 b for further processing. The processing unitcomponents of system 100 perform various signal processing functions ashave been described in detail in reference to FIG. 2. The processingunit may process signals that are mathematically combined, such as thecombining of neuron spikes that are first separated using spikediscrimination methods, these methods known to those of skill in theart. In alternative embodiments, the processing unit may comprisemultiple components or a single component; each of the processing unitcomponents can be fully implanted in patient 500, be external to thebody, or be implanted with a portion of the component exiting throughthe skin.

In FIG. 3, a first controlled device is a computer, CPU 305 that isattached to monitor 302 and integrated into configuration cart 121.Through the use of system 100, patient 500 can control one or morecomputer functions including but not limited to: an on/off function, areset function, a language function, a modem function, a printerfunction, an Internet function, a cursor, a keyboard, a joystick, atrackball or other input device. Each function may be controlledindividually or in combination. System 100 includes a second controlleddevice, wheelchair 310. Numerous other controlled devices can beincluded in the systems of this application, individually or incombination, including but not limited to: a computer; a computerdisplay; a mouse; a cursor; a joystick; a personal data assistant; arobot or robotic component; a computer controlled device; a teleoperateddevice; a communication device or system; a vehicle such as awheelchair; an adjustable bed; an adjustable chair; a remote controlleddevice; a Functional Electrical Stimulator device or system; a musclestimulator; an exoskeletal robot brace; an artificial or prostheticlimb; a vision enhancing device; a vision restoring device; a hearingenhancing device; a hearing restoring device; a movement assist device;medical therapeutic equipment such as a drug delivery apparatus; medicaldiagnostic equipment such as epilepsy monitoring apparatus; othermedical equipment such as a bladder control device, a bowel controldevice and a human enhancement device; closed loop medical equipment andother controllable devices applicable to patients with some form ofparalysis or diminished function as well as any device that may beutilized under direct brain or thought control in either a healthy orunhealthy patient.

Processing unit second portion 130 b includes a unique electronic ID,such as a unique serial number or any alphanumeric or other retrievable,identifiable code associated uniquely with the system 100 of patient500. The unique electronic identifier may take many different forms inprocessing unit second portion 130 b, such as a piece of electronic datastored in a memory module; a semiconductor element or chip that can beread electronically via serial, parallel or telemetric communication;pins or other conductive parts that can be shorted or otherwiseconnected to each other or to a controlled impedance, voltage or ground,to create a unique code; pins or other parts that can be masked tocreate a binary or serial code; combinations of different impedancesused to create a serial code that can be read or measured from contacts,features that can be optically scanned and read by patterns and/orcolors; mechanical patterns that can be read by mechanical or electricaldetection means or by mechanical fit, a radio frequency ID or otherfrequency spectral codes sensed by radiofrequency or electromagneticfields, pads and/or other marking features that may be masked to beincluded or excluded to represent a serial code, or any other digital oranalog code that can be retrieved from the discrete component.

Alternatively or in addition to embedding the unique electronic ID inprocessing unit second portion 130 b, the unique electronic ID can beembedded in one or more implanted discrete components. Under certaincircumstances, processing unit second portion 130 b or another externalor implanted component may need to be replaced, temporarily orpermanently. Under these circumstances, a system compatibility checkbetween the new component and the remaining system components can beconfirmed at the time of the repair or replacement surgery through theuse of the embedded unique electronic ID. The unique electronic ID canbe embedded in one or more of the discrete components at the time ofmanufacture, or at a later date such as at the time of any clinicalprocedure involving the system, such as a surgery to implant the sensorelectrodes into the brain of patient 500. Alternatively, the uniqueelectronic ID may be embedded in one or more of the discrete componentsat an even later date such as during a system configuration routine suchas a calibration routine.

Referring again to FIG. 3, processing unit second portion 130 bcommunicates with one or more discrete components of system 100 viawireless communication means. Processing unit second portion 130 bcommunicates with selector module 400, a component utilized to selectthe specific device or devices to be controlled by the processed signalsof system 100. Selector module 400 includes a touch screen set ofbuttons, input element 402, used to perform the selection process.Processing unit second portion 130 b also communicates with controlleddevice CPU 305, such as to control a cursor, joystick, keyboard or otherfunction of CPU 305. Processing unit second portion 130 b furthercommunicates with processing unit third portion 130 c. Processing unitthird portion 130 c provides additional signal processing functions, ashave been described above, to control wheelchair 310. An additionalprocessing unit discrete component, processing unit fourth portion 130d, is included to perform additional processing of the multicellularsignals and/or derivatives of these processed signals and/or processingof additional information, such collective processing used to controlone or more additional controlled devices of the present invention, notshown. System 100 of FIG. 3 utilizes selector module 400 to select oneor more of CPU 305, wheelchair 310 or another controlled device to becontrolled by the processed signals produced by the processing unit ofthe present invention. In system 100 of FIG. 3, one set of processedsignals emanate from one portion of the processing unit, processing unitsecond portion 130 b, and a different set of processed signals emanatefrom a different portion of the processing unit, processing unit thirdportion 130 c.

The various components of system 100 communicate with wirelesstransmission means, however it should be appreciated that physicalcables can be used to transfer data alternatively or in addition towireless means. These physical cables may include electrical wires,optical fibers, sound wave guide conduits, and other physical means oftransmitting data and/or power and any combination of those means.

Referring back to FIG. 3, a qualified individual, operator 110 incooperation with patient 500, is performing a patient training routine,one of numerous configuration programs or routines of the system. In analternative embodiment, patient 500 is the operator of the patienttraining routine or other configuration routine. The patient trainingroutine is shown being performed with controlled device 305. Displayedon monitor 302 is planned trajectory 711, system controlled target 712and patient controlled object 713. In the performance of the patienttraining routine, multiple time varying stimulus, such as a movingsystem controlled target 712 are provided to the patient such that thepatient can imagine moving that target, and a set of multicellularsignal data can be collected by the processing unit to produce one ormore algorithms to produce the processed signals of the presentinvention. In a preferred embodiment, after a first set of multicellularsignal data is collected, and a first transfer function for producingprocessed signals is developed, a second set of time varying stimulus isprovided in combination with a patient controlled object, such aspatient controlled object 713. During the time that the patient tries tomimic the motion of the system controlled target 712 with the visualfeedback of the patient controlled target 713, and a second set ofmulticellular signal data is collected and a second, improved transferfunction is produced by the system. Additional forms of feedback can beprovided to the patient, such as tactile transducer 701 shown attachedto patient 500's neck, and speaker 702 shown attached to processing unitthird portion 130 c fixedly mounted to the back of controlled wheelchair310. Speaker 702 and tactile transducer 701 can provide feedback in theform of a time varying stimulus, a derivative of the multicellularsignals, and/or a representation of the processed signals as controlledby patient 500.

In a preferred embodiment, one or more system configuration routines canbe performed without an operator, with the patient as the operator, orwith an operator at a remote location such as when the system of thepresent invention is electronically connected with a computer orcomputer network such as the Internet. In another preferred embodiment,the patient training routine must be performed at least one time duringthe use of the system, preferably before patient 500 is given, by thesystem, full control of one or more controlled devices. For example,limited control of CPU 305 may include the ability to send and receiveemail but not the ability to adjust a computer-controlled thermostat.Limited control of wheelchair 310 may be to turn left or right, but notmove forward or back, or to only allow travel at a limited velocity. Forthe purposes of this specification, limited control may also include nocontrol of one or more controlled devices. Each controlled device willhave different parameters limited by system 100 when patient 500 has notbeen given full control. In a preferred embodiment, the selection ofthese parameters; the values to be limited; the criteria for achievingfull control such as the value of a success threshold achieved during asystem configuration routine such as a patient training routine; andcombinations of these, are modified only in a secured way such as onlyby a clinician utilizing electronic or mechanical keys or passwords.

In addition to successful completion of the patient training routine,completion of one or more other configuration routines may be requiredfor patient 500 to have full control of one or more controlled devices,or multiple successful completions of a single routine. Success ispreferably measured through the measurement of one or more performanceparameters during or after the configuration routine. Success will beachieved by a performance parameter being above a threshold value, suchas a threshold adjustable only by a clinician, such as a clinician at aremote site utilizing a password, a user identification, an electronicID and/or a mechanical key. These configuration routines are utilized bythe system to not only determine the applicability of full control tothe patient, but to set or reset one or more system configurationparameters. System configuration parameters include but are not limitedto: selection of cellular signals for processing by the processing unit;criteria for the selection of cells for processing; a coefficient of asignal processing function such as amplification, filtering, sorting,conditioning, translating, interpreting, encoding, decoding, combining,extracting, sampling, multiplexing, analog to digital converting,digital to analog converting, mathematically transforming; a controlsignal transfer function parameter such as a transfer functioncoefficient, algorithm, methodology, mathematical equation, acalibration parameter such as calibration frequency; a controlled deviceparameter such as a controlled device boundary limit; acceptablefrequency range of cellular activity; selection of electrodes toinclude; selection of cellular signals to include; type of frequencyanalysis such as power spectral density; instruction information topatient such as imagined movement type or other imagined movementinstruction; type, mode or configuration of feedback during provision ofprocessed signals to patient; calibration parameter such as calibrationduration and calibration frequency; controlled device parameter such ascontrolled device mode; alarm or alert threshold; and a successthreshold.

As depicted in FIG. 3, operator 110 utilizes configuration apparatus 120which includes two monitors, first configuration monitor 122 a andsecond configuration monitor 122 b, configuration keyboard 123, andconfiguration CPU 125, to perform a calibration routine or other systemconfiguration process such as a patient training routine, algorithm andalgorithm parameter selection and output device setup. The configurationroutines, such as the patient training routine, include softwareprograms and hardware required to perform the configuration. Theembedded software and/or hardware may be included in the processingunit, such as processing unit second portion 130 b, be included inselector module 400, be incorporated into configuration apparatus 120, acontrolled device, or combinations of these. Configuration apparatus 120may include additional input devices, such as a mouse or joystick, or aninput device for a patient with limited motion, such as a tongue switch;a tongue palate switch; a chin joystick; a sip-and-puff joystickcontroller; an eye tracker device; a head tracker device; an EMG switchsuch as an eyebrow EMG switch; an EEG activated switch; and a speechrecognition device, all not shown.

Configuration apparatus 120 may include various elements, functions anddata including but not limited to: memory storage for future recall ofconfiguration activities, operator qualification routines, standardhuman data, standard synthesized or artificial data, neuron spikediscrimination software, operator security and access control,controlled device data, wireless communication means, remote (such asvia the Internet) configuration communication means and other elements,functions and data used to provide an effective and efficientconfiguration on a broad base of applicable patients and a broad base ofapplicable controlled devices. A system electronic ID can be embedded inone or more of the discrete components at the time, including an IDembedded at the time of system configuration. In an alternativeembodiment, all or part of the functionality of configuration apparatus120 is integrated into selector module 400 such that system 100 canperform one or more configuration processes such as a calibrationprocedure or patient training routine, utilizing selector module 400without the availability of configuration apparatus 120.

In order to change a system configuration parameter, system 100 includesa permission routine, such as an embedded software routine or softwaredriven interface that allows the operator to view information and enterdata into one or more components of system 100. The data entered mustsignify an approval of the parameter modification in order for themodification to take place. Alternatively, the permission routine may bepartially or fully located in a separate device such as configurationapparatus 120 of FIG. 3, or a remote computer such as a computer thataccesses system 100 via the Internet or utilizing wireless technologies.In order to access the permission routine, and/or approve themodification of the system configuration parameters, a password orsecurity key, mechanical, electrical, electromechanical or softwarebased, may be required of the operator. Multiple operators may be neededor required to approve a parameter modification. Each specific operatoror operator type may be limited by system 100, via passwords and othercontrol configurations, to approve the modification of only a portion ofthe total set of modifiable parameters of the system. Additionally oralternatively, a specific operator or operator type may be limited toonly approve a modification to a parameter within a specific range ofvalues, such as a range of values set by a clinician when the operatoris a family member. Operator or operator types, hereinafter operator,include but are not limited to: a clinician, primary care clinician,surgeon, hospital technician, system 100 supplier or manufacturertechnician, computer technician, family member, immediate family member,caregiver and patient.

In a preferred embodiment, the system 100 of FIG. 3 includes aninterrogation function, which interrogates the system to retrievecertain information such as on the demand of an operator. Based on theanalysis of the information, a recommendation for a parameter valuechange can be made available to the operator, such as by automaticconfiguration or calibration routines that are initiated by the operatorinitiated interrogation function. After viewing the modification, theappropriate operator would approve the change via the permissionroutine, such as using a computer mouse to click “OK” on a confirmationbox displayed on a display monitor, or a more sophisticated, passwordcontrolled methodology.

In a preferred embodiment, an automatic or semi-automatic configurationfunction or routine is embedded in system 100. This embeddedconfiguration routine can be used in place of a configuration routineperformed manually by Operator 110 as is described hereabove, or can beused in conjunction with one or more manual configurations. Automaticand/or semi-automatic configuration triggering event or causes can takemany forms including but not limited to: monitoring of cellularactivity, wherein the system automatically changes which particularsignals are chosen to produce the processed signals; running parallelalgorithms in the background of the one or more algorithms currentlyused to create the processed signals, and changing one or morealgorithms when improved performance is identified in the backgroundevent; monitoring of one or more system functions, such as alarm orwarning condition events or frequency of events, wherein the automatedsystem shuts down one or more functions and/or improves performance bychanging a relevant variable; and other methods that monitor one or morepieces of system data, identify an issue or potential improvement, anddetermine new parameters that would reduce the issue or achieve animprovement. In a preferred embodiment of the disclosed invention, whenspecific system configuration parameters are identified, by an automatedor semi-automated calibration or other configuration routine, to bemodified for the reasons described above, an integral permission routineof the system requires approval of a specific operator when one or moreof the system configuration parameters are modified.

Operator 110 may be a clinician, technician, caregiver, patient familymember or even the patient themselves in some circumstances. Multipleoperators may be needed or required to perform a configuration routineor approve a modification of a system configuration parameter, and eachoperator may be limited by system 100, via passwords and other controlconfigurations, to only perform or access specific functions. Forexample, only the clinician may be able to change specific criticalparameters, or set upper and lower limits on other parameters, while acaregiver, or the patient, may not be able to access those portions ofthe configuration procedure or the permission procedure. Theconfiguration routine includes the setting of numerous parameters neededby system 100 to properly control one or more controlled devices. Theparameters include but are not limited to various signal conditioningparameters as well as selection and de-selection of specificmulticellular signals for processing to generate the device controlcreating a subset of signals received from the sensor to be processed.The various signal conditioning parameters include, but are not limitedto, threshold levels for amplitude sorting, other sorting and patternrecognition parameters, amplification parameters, filter parameters,signal conditioning parameters, signal translating parameters, signalinterpreting parameters, signal encoding and decoding parameters, signalcombining parameters, signal extracting parameters, mathematicalparameters including transformation coefficients and other signalprocessing parameters used to generate a control signal for transmissionto a controlled device.

The configuration routine will result in the setting of various systemconfiguration output parameters, all such parameters to be consideredsystem configuration parameters of the system of the present invention.Configuration output parameters may include but are not limited to:electrode selection, cellular signal selection, neuron spike selection,electrocorticogram signal selection, local field potential signalselection, electroencephalogram signal selection, sampling rate bysignal, sampling rate by group of signals, amplification by signal,amplification by group of signals, filter parameters by signal andfilter parameters by group of signals. In a preferred embodiment, theconfiguration output parameters are stored in memory in one or morediscrete components, and the parameters are linked to the system'sunique electronic ID.

Calibration, patient training, and other configuration routines,including manual, automatic and semi-automatic routines, may beperformed on a periodic basis, and may include the selection anddeselection of specific cellular signals over time. The initialconfiguration routine may include initial values, or starting points,for one or more of the configuration output parameters. Setting initialvalues of specific parameters, may invoke a permission routine.Subsequent configuration routines may involve utilizing previousconfiguration output parameters that have been stored in a memorystorage element of system 100. Subsequent configuration routines may beshorter in duration than an initial configuration and may require lesspatient involvement. Subsequent configuration routine results may becompared to previous configuration results, and system 100 may require arepeat of configuration if certain comparative performance is notachieved.

The configuration routine may include the steps of (a) setting apreliminary set of configuration output parameters; (b) generatingprocessed signals to control the controlled device; (c) measuring theperformance of the controlled device control; and (d) modifying theconfiguration output parameters. The configuration routine may furtherinclude the steps of repeating steps (b) through (d). The configurationroutine may also require invoking a permission routine.

In the performance of a configuration routine, the operator 110 mayinvolve patient 500 or perform steps that do not involve the patient. Inthe patient training routine and other routines, the operator 110 mayhave patient 500 imagine one or more particular movements, imaginedstates, or other imagined events, such as a memory, an emotion, thethought of being hot or cold, or other imagined event not necessarilyassociated with movement. The patient participation may include thepatient training routine providing one or more time varying stimulus,such as audio cues, visual cues, olfactory cues, gustatory cues, tactilecues, moving objects on a display such as a computer screen, movingmechanical devices such as a robotic arm or a prosthetic limb, moving apart of the patient's body such as with an exoskeleton or FES implant,changing audio signals, changing electrical stimulation such as corticalstimulation, moving a vehicle such as a wheelchair or car; moving amodel of a vehicle; moving a transportation device; and other sensorystimulus. The imagined movements may include the imagined movement of apart of the body, such as a limb, arm, wrist, finger, shoulder, neck,leg, angle, and toe, as well as imagining moving to a location, movingin a direction and moving at a velocity or acceleration.

Referring back to FIG. 3, the patient imagines moving system controlledtarget 712 along planned trajectory 711, as target 712 is moving ascontrolled by the system or manually by an operator. The currentprocessed signal, hereinafter a representation of the processed signal,available by applying a transfer function to the multicellular signalsdetected during the imagined movement or other step of the patienttraining routine, is displayed in the form of control of patientcontrolled target 713. The transfer function is preferably based onmulticellular signals stored during a previous imagined movement, ormultiple previous imagined movements, preferably two or more sets ofstates of time varying stimulus. The representation of the processedsignals may mimic the time varying stimulus, similar to patientcontrolled object 713 being a similar form to system controlled object712. Alternatively, the time varying stimulus and representation of theprocessed signals may take different forms, such as a time varyingstimulus comprising an object on a visual display, wherein therepresentation comprises a moving mechanical structure, or the stimulusbeing a moving mechanical structure and the representation comprising anobject on a visual display. The representation of the processed signalscan be provided to the patient in visual form such as a visualrepresentation of limb motion displayed on a computer monitor, or in oneor more sensory forms such as auditory, olfactory, gustatory, andelectrical stimulation such as cortical stimulation. The representationof the processed signals can be provided in combinations of these andother forms.

In a preferred embodiment, the first patient training step does notinclude patient controlled object 713 or it includes a patientcontrolled target whose processed signals are not based on a set ofmulticellular signals collected during a previous imagined movement.Multiple steps of providing a set of states of the time varying stimulusand recording the multicellular signal data may involve differentsubsets of cells from which the multicellular signals are detected.Also, different sets of states of time varying stimulus may havedifferent numbers of cells in each. Alternative to the system controlledtarget 712 along planned trajectory 711, the patient may imaginemovements while viewing a time varying stimulus comprising a video oranimation of a person performing the specific movement pattern. In apreferred embodiment, this visual feedback is shown from the patient'sperspective, such as a video taken from the person performing themotion's own eye level and directional view. Multiple motion patternsand multiple corresponding videos may be available to improve orotherwise enhance the patient training process. The patient trainingroutine temporally correlates a set of states of the time varyingstimulus with the set of multicellular signal signals captured andstored during that time period, such that a transfer function can bedeveloped for future training or controlled device control. Correlationscan be based on numerous variables of the motion including but notlimited to: position, velocity and acceleration of the time varyingstimulus; a patient physiologic parameter such as heart rate; acontrolled device parameter; a system environment parameter; a passwordcontrolled parameter; a clinician controlled parameter; and a patienttraining routine parameter. In the patient training routine of FIG. 3,the controlled device, CPU 305 and controlled monitor 302 are used inthe patient training routine to display the time varying stimulus aswell as the representation of the processed signal. In a subsequentstep, wheelchair 310 can also be employed, such as by a systemcontrolling the wheelchair while the patient imagines the control, thewheelchair movement being the time varying stimulus.

During the time period that a set of states of the time varying stimulusis applied, multicellular signal data detected by the implanted sensoris stored and temporally correlated to that set of states of the timevarying stimulus provided to the patient. In a preferred embodiment, thesystem of the present invention includes a second patient trainingroutine and a second controlled device, wherein the first patienttraining routine is used to configure the first controlled device andthe second patient training routine is used to configure the secondcontrolled device. The two patient training routines may includedifferent time varying stimulus, chosen to optimize the routine for thespecific controlled device, such as a moving cursor for a computer mousecontrol system, and a computer simulated prosthetic limb for aprosthetic limb control system. In a preferred system, the firstcontrolled device is a prosthetic arm and the second controlled deviceis a prosthetic leg, this system having two different time varyingstimulus in the two corresponding patient'training routines. In anotherpreferred system, the first controlled device is a prosthetic arm andthe second controlled device is a wheelchair, this system also havingtwo different time varying stimulus in the two corresponding patientroutines. In an alternative, preferred embodiment, a controlled devicesurrogate is utilized in the patient training routine. The controlleddevice surrogate preferably has a larger value of one or more of:degrees of freedom; resolution; modes; discrete states; functions; andboundary conditions. Numerous boundary conditions with greater valuesfor the surrogate device can be employed, such boundary conditions as:maximum distance; maximum velocity; maximum acceleration; maximum force;maximum torque; rotation; and position. The surrogate device employinglarger values of these parameters creates the scenario wherein thepatient is trained and/or tested with a device of more complexity thanthe eventual controlled device to be used.

The time varying stimulus may be supplied to the patient in numerousforms such as visual, tactile, olfactory, gustatory, and electricalstimulation such as cortical stimulation. The time varying stimulus maybe moved around manually, automatically produced and controlled by acomponent of the system such as the processing unit, or produced by aseparate device. The time varying stimulus may include continuous orsemi-continuous motion of an object, such as an object moving on avisual display, a mechanical object moving in space, or a part of thepatient's body moving in space. The time varying stimulus may be of ashort duration, such as an object appearing and disappearing quickly ona display, or a flash of light.

In a preferred embodiment, the patient training routine includesmultiple forms of feedback, in addition to the time varying stimulus,such feedback provided to the patient in one or more forms including butnot limited to: visual; tactile; auditory; olfactory; gustatory; andelectrical stimulation. The additional feedback may be a derivative ofthe multicellular signals, such as visual or audio feedback of one ormore neuron spike modulation rates. Different forms of feedback may beprovided as based on a particular device to be controlled by theprocessed signals. Numerous parameters for the time varying stimulus andother feedback may be adjustable, such as by the operator or patient,these parameters including but not limited to: sound volume andfrequency; display brightness, contrast, size and resolution; displayobject size; electrical current parameter such as current or voltage;mechanical or visual object size, color, configuration, velocity oracceleration; and combinations of these.

A configuration routine such as a calibration or patient trainingroutine will utilize one or more configuration input parameters todetermine one or more system output parameters used to develop aprocessed signal transfer function. In addition to the multicellularsignals themselves, system or controlled device performance criteria canbe utilized. Other configuration input parameters include variousproperties associated with the multicellular signals including one ormore of: signal to noise ratio, frequency of signal, amplitude ofsignal, neuron firing rate, average neuron firing rate, standarddeviation in neuron firing rate, modulation of neuron firing rate aswell as a mathematical analysis of any signal property including but notlimited to modulation of any signal property. Additional configurationinput parameters include but are not limited to: system performancecriteria, controlled device electrical time constants, controlled devicemechanical time constants, other controlled device criteria, types ofelectrodes, number of electrodes, patient activity during configuration,target number of signals required, patient disease state, patientcondition, patient age and other patient parameters and event based(such as a patient imagined movement event) variations in signalproperties including neuron firing rate activity. In a preferredembodiment, one or more configuration input parameters are stored inmemory and linked to the embedded, specific, unique electronicidentifier. All configuration input parameters shall be considered asystem configuration parameter of the system of the present invention.

It may be desirous for the configuration routine to exclude one or moremulticellular signals based on a desire to avoid signals that respond tocertain patient active functions, such as non-paralyzed functions, oreven certain imagined states. The configuration routine may includehaving the patient imagine a particular movement or state, and based onsufficient signal activity such as firing rate or modulation of firingrate, exclude that signal from the signal processing based on thatparticular undesired imagined movement or imagined state. Alternativelyreal movement accomplished by the patient may also be utilized toexclude certain multicellular signals emanating from specific electrodesof the sensor. In a preferred embodiment, an automated or semi-automatedcalibration or other configuration routine may include through addition,or exclude through deletion, a signal based on insufficient activityduring known patient movements.

The configuration routines of the system of the present invention, suchas a patient training routine in which a time varying stimulus isprovided to the patient, may conduct adaptive processing, such asadapting between uses or within a single patient training routine. Theadaptation may be caused by a superior or inadequate level ofperformance, as compared to a threshold value, such as an adjustablethreshold. In a preferred embodiment, performance during a patienttraining routine above a threshold value causes the duration of theroutine to decrease, and performance below a threshold value causes theduration of the routine to increase. Control of the controlled device orsurrogate controlled device is a preferred way of measuring performance.Alternatively, a change in multicellular signals, such as a change inmodulation rate may cause an adaptation to occur. A monitored differenceis a first patient training event and a second patient training event,such as a difference in signal modulation, may cause an adaptation inthe patient training routine, such as to preferentially choose one timevarying stimulus over another time varying stimulus. Other causesinclude a change to a patient parameter, such as the level of patienceconsciousness. In a preferred embodiment, at a low level ofconsciousness, the patient training routine changes or discontinues. Thelevel of consciousness may be determined by the multicellular signalsdetected by the sensor. Alternatively, the level of consciousness can bedetected utilizing a separate sensor, such as a sensor to detect EEG orLFP signals. The patient training routine may adapt automatically, suchas due to a calculation performed by the processing unit, or may adaptdue to operator input.

The systems of the present invention, such as system 100 of FIG. 3,include a processing unit that processes multicellular signals receivedfrom patient 500. Processing unit second portion 130 b and otherprocessing unit components, singly or in combination, perform one ormore functions. The functions performed by the processing unit includebut are not limited to: producing the processed signals; transferringdata to a separate device; receiving data from a separate device;producing processed signals for a second controlled device; activatingan alarm, alert or warning; shutting down a part of or the entiresystem; ceasing control of a controlled device; storing data andperforming a configuration.

In order for the processing unit of system 100 to perform one or morefunctions, one or more system configuration parameters are utilized.These parameters include pieces of data stored in, sent to, or receivedfrom, any component of system 100, including but not limited to: thesensor; a processing unit component; processing unit second portion 130b; or a controlled device. Parameters can be received from devicesoutside of system 100 as well, such as configuration apparatus 120, aseparate medical therapeutic or diagnostic device, a separate Internetbased device or a separate wireless device. These parameters can benumeric or alphanumeric data, and can change over time, eitherautomatically or through an operator involved configuration or otherprocedure.

The processing unit, or other component of system 100 may producemultiple processed signals for controlling one or more controlleddevice. This second processed signals may be based on multicellularsignals of the sensor, such as the same set of cells as the firstprocessed signals are based on, or a different set of cells emanatingsignals. The signal processing used to produce the additional processedsignals can be the same as the first, or utilize different processing,such as different transfer functions. Transfer functions may includedifferent algorithms, coefficients such as scaling factors, differenttypes of feedback, and other transfer function variations.Alternatively, the additional processed signals may be based on signalsnot received from the sensor in which the first processed signals arederived. An additional sensor, such as a similar or dissimilar sensor,may provide the signals to produce the additional processed signals, orthe system may receive a signal from an included input device such as atongue switch; tongue palate switch; chin joystick; sip-and-puffjoystick controller; eye gaze tracker; head tracker; EMG switch such aseyebrow EMG switch; EEG activated switch; speech recognition device; andcombinations thereof. The additional processed signals may be derivedfrom a monitored biological signal such as a signal based on eye motion;eyelid motion; facial muscle activation or other electromyographicactivity; heart rate; EEG; LFP; respiration; and combinations thereof.In creating the additional processed signals, the processing unit mayconvert these alternative input signals into a digital signal, such as adigital signal used to change the state of the system, such as a changein state of an integrated configuration routine.

Referring now to FIG. 4 a and FIG. 4 b, the patient training displayincluding the representation of a human figure of the present inventionis illustrated. Module 400 is a visual display, such as a color LCDdisplay or a touch screen monitor. Module 400 displays a human figure inthe form of a computer generated image of a man. In FIG. 4 a, the man isdepicted with both arms on a surface such as a desk, with the left handin an open fist, palm up configuration. FIG. 4 b depicts the same man atthe desk, and the only change is the left hand is now in a closed fistconfiguration. Human FIG. 403 may have been presented in the form of acontinuous motion animation such that the patient performing the patienttraining routine or the system troubleshooting routine sees thecontinuous change in the hand such as the curling in of the fingers.Alternatively, human FIG. 403 may be presented in the form of discreteimages, such as the two images of FIG. 4 a and FIG. 4 b. In a preferredembodiment, the patient or other operator, utilizing the patient inputswitch or other type of input device described in detail hereabove, maychange one or more properties of human FIG. 403. In one embodiment, thegender can be changed from the man of FIG. 4 a and FIG. 4 b to a woman.In another embodiment, the relative age of the man in FIG. 4 a and 4 bmay also be changed. In yet another embodiment, the side of the body ofthe limbs used, such as changing from the left to the right hand in FIG.4 a and FIG. 4 b, can be accomplished.

Module 400 may include one or more speakers, not shown, to provide audiofeedback such as a time varying stimulus including audible information.The audio feedback may include spoken language, such as spoken wordsthat can be presented in one or more languages as selected by thepatient or other operator of the system. Multiple other forms offeedback can be provided to the patient, such as via transducersintegral to module 400 or implanted in or attached to the patient. Thesetransducers can provide feedback is a form selected from the groupconsisting of: visual; tactile; auditory; gustatory; olfactory; taste;electrical stimulation; and combinations thereof. In an alternativeembodiment, visual images, such as camera pictures or continuous imagesfrom a video camera, can be used in addition or alternative to thecomputer images of FIG. 4 a and FIG. 4 b. One or more actors and/oractresses can be used, such as actors selected from multiple genders,age groups, nationalities, spoken language type, and other variations,the actors performing multiple human body movements and was as othertasks presented in visual form to the patient in the performance of thepatient training routine or system troubleshooting of the presentinvention.

Referring now to FIG. 5, another preferred embodiment of the presentinvention is illustrated in which a biological interface system includesan integrated patient training routine and/or a system troubleshootingroutine. The patient training routine or system troubleshooting routineis conducted with an operator, such as a technician or healthcareworker. This operator is at a location remote from the patient and usesa remote access routine that provides data transfer means to allow theremote operator to send and/or receive data to or from one or moresystem components. The patient training routine and/or systemtroubleshooting routine can be conducted with patient involvement, ormay be performed wherein the patient is unaware of the remote operator.The patient training routine and/or system troubleshooting routine isperformed to generate one or more system configuration parameter values.In a preferred embodiment, the system configuration parameters generatedare used to create a transfer function used by the processing unit toapply to the multicellular signals to produce processed signalstransmitted to one or more devices to be controlled.

Patient 500 has been implanted with a sensor, not shown, such as asensor implanted in the motor cortex of the patient's brain. Processingunit first portion 130 a is removably attached to a connector on thepatient's skull, connector not shown, which is electrically attached toeach of the electrodes of the implanted sensor. Patient 500 may utilizean input device, not shown, such as a tongue switch and/or other inputdevice described in detail hereabove. The patient input device can beused to perform one or more functions integral to the patient trainingroutine and/or system troubleshooting routine. Processing unit firstportion 130 a transmits signals to processing unit second portion 130 bvia intra-processing unit cable 131. Processing unit second portion 130b transmits signals to a controlled device, patient computer 470 viawireless transceiver 135 of processing unit second portion 130 b andtransceiver 472 of patient computer 470. Cable 131 includes one or moreof electrical conduits and fiber optic conduits. In alternativeembodiments, cable 131 is eliminated through the use of wirelesscommunication means, such as RF communication means.

Patient computer 470 is positioned in a location such that the patientcan visualize the video monitor of patient computer 470 and the visualrepresentation of the human figure of the present invention can beprovided to the patient. In a preferred embodiment, the patient imaginesone or more movements or imagined states, while the human figure isprovided, such that a set of multicellular signals can be detected andstored in system memory, this set of data is used to generate one ormore system configuration parameters. Patient computer 470 can have oneor more functions, such as cursor, keyboard, joystick, mouse, or otherinput device control, controlled by the processed signals of system 100.Patient computer 470 may include a portion of the processing unit, suchthat final signal processing is performed by the electronics of patientcomputer 470. In an alternative embodiment, patient computer 470incorporates all of the functions of processing unit second portion 130b, which is then eliminated. In addition, patient computer 470 may be asurrogate or intermediate for another controlled device such thatpatient 500 utilizes patient computer 470 to control a separate externaldevice such as a robot, a thermostat or numerous other devicescontrollable through a computer interface. In addition, patient computer470 may function, in whole or in part, as the system configurationapparatus, such as configuration apparatus 120 of FIG. 3, thus reducingthe need for multiple computers, computer monitors, etc.

Patient computer 470 is attached to the Internet via communication means471. In alternative embodiments patient computer 470 may bealternatively or additionally attached to a different network ofcomputers, such as a local group of computers, a LAN, a WAN, a WIFIconnection, or other single or group of computers or other electronicdevices in proximity to or remote from the patient's location. Computercommunication means 471 may include one or more of a phone cable andmodem, a cable modem, a network routing device, a wireless transmissiondevice, a wireless phone and/or other communication device and/orconduit. In an alternative embodiment, a second remote operator at athird location is required to complete the patient training routine orthe system troubleshooting routine of the present invention.

As depicted in FIG. 5, system 100 further includes technician computer460, a separate computer at a location remote from patient 500 such as ahospital or service center of the manufacturer or provider of system100. Utilizing technician computer 460 is technician operator 450, anoperator of the biological interface system 100 of the presentinvention. Technician operator 450 is knowledgeable of system 100.Technician operator 450 uses technician computer 460 to access patientcomputer 470 such as via the Internet utilizing computer communicationmeans 461. Through patient computer 470, one or more components ofsystem 100 can be accessed such as processing unit second portion 130 b,processing unit first portion 130 a and potentially the sensor, notshown.

The remote access provided in system 100 of FIG. 5 is beneficial inallowing the patient training routine and/or system troubleshootingroutine of the present invention to be performed by a remote operator,avoiding the need to visit patient 500's location. Other systemconfiguration routines such as those that result in calibrations, othersystem improvements, and other parameter modifying events may beperformed while one or more operators are at a remote location. In apreferred embodiment, technician operator 450 approves one or moresystem configuration parameter values that are set or modified,utilizing system 100's permission routine. Prior to making the approval,technician operator 450 may run one or more tests, with or withoutpatient involvement, and approve the modification only upon successfulresults from those tests.

Nurse groups, clinical care organizations, clinical researchorganizations, rehabilitation groups, health care financial providerssuch as Blue Cross and other applicable groups may access the system forthe benefit of the patient, the health care system or both. System 100of the present invention can be configured to allow a single or multipleoperators, these operators located at the patient site, remotely orboth, to change one or more system configuration parameters utilized bythe processing unit to perform a function. Integrated into one or morecomponents of system 100 is a permission routine that requires anoperator, such as technician operator 450 of FIG. 5, to provide anapproval of the modification of one or more parameters. The permissionroutine can be implemented through the use of technician computer 460wherein technician operator 450 uses an input device such as a mouse orkeyboard to enter information confirming the acceptability of thechange. Each parameter modification may be linked with one or morehealthcare fees, such as a clinician fee wherein the operator performingthe patient training routine or system troubleshooting routine of thepresent invention is a clinician. In a preferred embodiment, system 100records these billable events and makes them available to technicianoperator 450 on demand.

There may be various reasons for the patient training routine or systemtroubleshooting routine to be performed. The resultant systemconfiguration parameter modifications may improve performance, safety,longevity of use such as battery life, allow additional external devicesto be controlled, and other progressive changes in a complex system.These routines may be invoked due to one or more of the following:adaptive processing of the system; alarm or warning condition; a changein patient performance; a change in patient condition; a cellular signalchange such as a modulation change; the initial setting of a systemconfiguration parameter; adding a new device to be controlled, such aswhen adequate performance is achieved during a test; and removal of acontrolled device such as when inadequate performance has beenidentified.

In a preferred embodiment, the permission routine includes one or moreembedded software routines which link specific operator approval withchanges to specific parameters, such as via a lookup table stored inelectronic memory. One or more computers or other data entry devices areused by system 100 to perform the permission routine. In a preferredembodiment, a dialog box appears on the monitor of technician computer460 including the parameter description, current value, proposed newvalue, and an “OK” box that the clinician clicks with the mouse toapprove the change. Approval can be signified by typing a code on one ormore keyboards or other text entry devices in communication with thesystem, clicking or otherwise activating a specific icon on a display,clicking a mouse at one or more specific locations on a display, andentering approval data via spoken voice into a voice recognition system.In an alternative embodiment, a second confirmation, such as an “ARE YOUSURE” dialog box, is utilized after a first approval. In anotheralternative embodiment, the operator can approve multiple parametermodifications with a single action, such as a confirmatory mouse click.In another alternative embodiment, approval is required by two or moreoperators. In another alternative embodiment, the permission routinerequires the operator to perform a task, such as entering a securitycode, performing a system test, performing a patient task such ascontrol of a controlled device with modified parameters, or other taskprior to or in conjunction with approving the parameter change with oneof the various means described above.

System configuration parameters can be stored within one or morecomponents of system 100, transmitted from one or more components ofsystem 100 or received by one or more components of system 100. Systemconfiguration parameters can include the various patient specificvalues, coefficients and other variables that are set and/or changed inthe performance of the patient training routine or systemtroubleshooting routine of the present invention. System configurationparameters include spike sorting variables such as amplitude thresholdvariables. System configuration parameters can include signal processingvariables such as sampling rate by signal, sampling rate by group ofsignals, amplification by signal, amplification by group of signals,filter parameter by signal, filter parameter by group of signals,sorting variable, conditioning variable, translating variable,interpreting variable, encoding variable, decoding variable, extractingvariable, mathematical transformation variable, signal to noise ratiovariable, frequency of signal variable, amplitude of signal variable,neuron firing rate variable, standard deviation in neuron firing ratevariable and modulation of neuron firing rate variable. Systemconfiguration parameters may include signal selection variablesincluding but not limited to: electrode selection variable, cellularsignal selection variable, neuron spike selection variable,electrocorticogram signal selection variable, local field potentialselection variable and electroencephalogram signal selection variable.

System configuration parameters may also include one or more controlleddevice parameters including but not limited to: allowed devices that thepatient can control; unique ID for device such as that used by ahandshaking protocol in order to achieve secure and accurate signaltransfer; parameter indicating partial control of a multi-functiondevice; movement parameter of device; a position, velocity,acceleration, torque, direction and/or momentum variable of a devicesuch as a maximum velocity parameter; a power parameter; a therapeuticdevice parameter such as dose amount, time for start of dose, rate ofdose, duty cycle of dose and amount of energy such as stimulationenergy; mechanical time constant variable and electrical time constantvariable. Additional system configuration parameters may also include: alist of permissions for specific operator or operator types; operatorusernames; operator passwords; on or off variables; system resetparameters; maximum on time of system parameters and allowable times ofday for system use by the patient.

Additional system configuration parameters may include calibrationparameters including but not limited to: electrode selection; cellularsignal selection; neuron spike selection; electrocorticogram signalselection; local field potential signal selection; electroencephalogramsignal selection; sampling rate by signal; sampling rate by group ofsignals; amplification by signal; amplification by group of signals;filter parameters by signal and filter parameters by group of signals;patient activity during calibration; target number of signals required;patient disease state; patient condition; patient age and other patientparameters. Additional system configuration parameters may includesystem performance criteria including but not limited to: target numberof signals required; patient disease state; patient condition; patientage and other patient parameters. Additional system configurationparameters include but are not limited to: algorithm selectionparameter; group of mathematical algorithms parameter; informationupload command; information download command; alarm, warning or alertparameter; criteria to determine adequate performance of system; failurethreshold parameter.

Numerous protection schemes can be included in system 100 to preventunauthorized representation of a user including but not limited topassword schemes, IP address confirmation, operator ID hardware such asfingerprint or retinal scan identification hardware as well aselectromechanical and mechanical keys. In a preferred embodiment, system100 further comprises an operator validation routine, using the measureslisted above and other measures to confirm the identification of one ormore operators. In another preferred embodiment, the system includes alogin function, wherein each operator enters one or more of a user name,a user group, a user ID and a password. The login function may ensurethat a mechanical or electronic key is in place at a specific port onthe system, not shown. The login function may upload various pieces ofinformation, such as from a remote computer, including IP address,electronic key information, computer login information and otherinformation.

Permission routines may be required by a second operator, such as when afirst operator determines a system configuration parameter to bechanged, a second operator must confirm the acceptability of the change.Numerous alternatives can be anticipated by those skilled in the art,without departing from the spirit and scope of this application, whereinone or more operators are required by the system to approve amodification to a system configuration parameter. In some instances, theparameter may remain unchanged until the approval is received, while inother instances a temporary period, such as a tryout period, may use thesystem with the parameter modified, requiring the approval to maintainthe modification for an extended period of time.

Numerous operators can be defined as applicable to system 100 includingbut not limited to clinicians, caregivers, care providers, technicians,patient family members and the patients themselves. A matrix ofpermission parameters can be included in system 100 such that specificparameter modifications can only be modified and/or approved byparticular operators. Defined levels for operators and operator groupscan be established to control certain groups of parameters.Alternatively or additionally, the value ranges, within which certainparameters can be modified, can also be operator specific. In apreferred embodiment, a limited, or relatively small number ofparameters can be approved for modification by the patient.

In a preferred embodiment, the system 100 of FIG. 5 includes aninterrogation function that interrogates the system to retrieve certaininformation. Based on the analysis of the information, a recommendationfor a patient training routine or system troubleshooting routine of thepresent invention may be indicated and/or required. In another preferredembodiment, system 100 of FIG. 5 includes a test routine. The testroutine can be run any time by an operator, at the patient site orremotely, in determining whether or not a parameter should be changed,in determining the final value for the change, or to confirm orotherwise test the change. For certain parameters, in addition to theapproval required by the permission routine, system 100 may require thetest routine be run. In yet another preferred embodiment, a successfulperformance during the test is also required for parameter modification.

In another preferred embodiment, the system 100 of FIG. 5 furthercomprises a monitoring routine. The monitoring routine is used by system100 to automatically monitor system performance and other systemparameters and provide, to one or more operators, a recommendation formodifying one or more of the system configuration parameters used by theprocessing unit, such as processing unit first portion 130 a and/orprocessing unit second portion 130 b, to perform a function. Therecommendation will include the identification of a system configurationparameter to be modified, but may also include a recommendation orrequirement to perform the patient training routine or systemtroubleshooting routine of the present invention. The recommendation canbe based on an analysis of real time or historic data, includingcellular signals such as neural signals, and other information. In apreferred embodiment, the monitoring routine modifies the parameter fora limited time period without operator approval, such as to allow thepatient limited control of the controlled device, such as to communicatevia system 100, potentially to a technician about an issue requiring theparameter modification. At a predetermined time, the parametermodification may revert back or the system performance may be otherwisemodified such as ceasing control of one or more controlled devices. Themonitoring routine includes software embedded in one or more componentsof system 100 that perform the analysis and monitoring. The monitoringroutine may get information from the sensor of system 100 as well asother physiologic and non-physiologic sensors, such as sensorsmonitoring the patient, the system environment, and/or the controlleddevice. The monitoring routine may itself include one or more systemconfiguration parameters, such as those requiring operator approval viathe permission routine of the present invention. The monitoring routinemay involve an analysis of raw cellular signal information, processed,or a derivative of the cellular signal information, controlled deviceinformation, patient physiologic information, environment informationand other information.

In another preferred embodiment, system 100 includes a systemconfiguration parameter modification notification function, preferablyactivated automatically by the system, which notifies an operator, ormultiple operators, of a suggested or pending change. The notificationfunction may require that the parameter modification be made, andpotentially tested, before performing the notification function. Thesystem configuration parameter modification notification function may beinitiated by the monitoring function, calibration functions andconfiguration functions described in detail hereabove. The notificationto the operator can take the form of one or more of: audible alert; avisual alert; olfactory cues; tactile feedback; email; phone call ormessage; and other information sent via wired and wireless means.Modification of certain parameters that have been notified to theoperator by the notification function will require approval of theoperator via the permission routine. This approval may be requiredbefore the parameter is modified, or a short time thereafter. Theoperator may perform a test, or may be required to perform a test, toconfirm acceptability of the modification.

In another preferred embodiment, system 100 further comprises a patientconfirmation routine, such as a software routine embedded in one or morecomponents of system 100. The patient confirmation routine requires thatthe patient, after temporarily controlling the device with new valuesfor one or more system configuration parameters, confirm theacceptability of these modifications. After the acceptability has beenconfirmed, continuous or long-term full control of the controlled devicewith the now tested parameter modifications is provided.

In situations where patient 500 may be at a location remote fromcaregivers or family members, it may be desirous for system 100 toinclude a means for a disabled patient to turn on or off one or morecomponents of system 100, or even reset the system. Switches thatcontrol these functions can be driven by eye motion, eyelid motion,facial muscle motion or other electromyographic activity. Alternatively,the switches could be driven by neural information or processed neuralinformation, such as a timecode of brain activity.

Referring now to FIG. 6, a flow chart of the patient training routine ofan additional embodiment of the biological interface system of thepresent invention is illustrated comprising multiple steps andconditional statements that determine the progression from step to step.The patient training routine is included in a software program or moduleembedded in one or more components of the system such as the processingunit. Alternatively, an additional component is included in the system,such as a computer system used to configure the system, and the patienttraining routine, or a portion of the patient training routine isembedded in whole or in part in the additional component. The patienttraining routine may be activated automatically by the system, or anoperator of the system, such as the patient's clinician or the patientthemselves, may initiate and/or conduct the patient training routine.

Referring back to FIG. 6, Step 20 includes the patient training routineproviding to the patient a series of steps whose order and tasks make upa system configuration plan. Step 21 includes providing to the patient aset of states of a time varying stimulus. The time varying stimulus canprovide a target for a patient's imagined movement and/or simply be atrigger to initiate the imagined movement or other imagined state. Thetime varying stimulus can be provided in multiple forms such as: visual;tactile; auditory; olfactory; gustatory; electrical stimulation such ascortical stimulation; and combinations thereof. The time varyingstimulus may be provided in many different types such as: computer icon;visual display object such as the visual representation of the humanfigure as described in reference to FIG. 1; moveable mechanical assemblysuch as a robotic arm; vehicle such as a wheelchair; single ormulti-frequency sound; stimulation electrode such as corticalstimulation electrode; robot or robotic component; tactile transducersuch as vibrating skin patch; and combinations thereof. The time varyingstimulus can include continuous or semi-continuous motion such as anicon moving on a computer screen. The time varying stimulus can includea mechanical object moving in space, such as a robotic arm or aprosthetic limb. The time varying stimulus can be provided via one ormore controlled devices of the system, such as an exoskeleton device orFES device moving one of the patient's own limbs. The time varyingstimulus may be provided as a short duration stimulus, such as an objectthat appears on a visual display for less than one second, or a briefflash of light.

In a preferred embodiment, the time varying stimulus has an adjustableparameter, such as a parameter adjustable in a secured manner such asvia the permission routine described hereabove. One or more parametersof the time varying stimulus may have a range of applicable values, suchas a range of position of a cursor or human figure on a computer screen,and these types of ranges may be an adjustable parameter. Otheradjustable parameters include but are not limited to: display brightnessor contrast; display size; display resolution; electrical currentparameter such as current or voltage; object velocity, acceleration andposition; object size and color; sound volume; sound frequency; tactilesensor force, frequency and pulse width; and combinations thereof. Theadjustment to a time varying stimulus parameter may be accomplished byone or more components of the system, such as the processing unit. Theadjustment may be accomplished by one or more users of the system, suchas the patient utilizing an input device as has been describedhereabove.

Referring back to FIG. 6, Step 21 further includes the step of recordingand storing, such as in electronic memory of a system component such asthe processing unit, a first set of multicellular signals simultaneouswith the patient imagining a movement associated with the provided setof states of the time varying stimulus. In a preferred embodiment, in aprevious step, not shown, the patient has viewed the set of states ofthe time varying stimulus at least one time prior to the recording ofthe first set of multicellular signals. The first set of cellularsignals are correlated, or mapped, to the set of states of the timevarying stimulus. The correlation can be synchronized in time, calledtemporal mapping, or correlated to another parameter including but notlimited to: a patient physiologic parameter such as heart rate; acontrolled device parameter; a system environment parameter; a passwordcontrolled parameter; a clinician controlled parameter; a patienttraining routine parameter; and combinations thereof. In addition to thesensor detecting the multicellular signals, one or more additionalsensors can be incorporated into the system. These sensors can beselected from the group consisting of: EKG sensor; respiration sensor;blood glucose sensor; temperature sensor; blood pressure and otherpressure sensors; EEG sensor; perspiration sensor; cellular signalactivity including neural activity sensor; skin conductance and otherimpedance sensor; strain gauge; light sensor; and combinations thereof.Numerous types of data can be collected and correlated to the timevarying stimulus such as: patient physiologic data; object or patientmotion data including data collected from a video recording device;system environment data; controlled device data; and other data. Patientphysiologic data can be selected from the group consisting of: EKG;respiration; blood glucose; temperature; blood pressure; EEG;perspiration; cellular signal activity including neural activity; skinconductance; and combinations thereof. In an alternative embodiment,step 21 includes the recording of patient or other data without theproviding of a time varying stimulus. In another alternative embodiment,step 21 does not include correlating the stored data with the timevarying stimulus.

Step 22 includes an analysis of one or more sets of data that arecollected during step 21, such as the multicellular signals, otherpatient physiologic data, one or more time varying stimulus sets ofdata, and other data. The analysis may require controlled device datasuch as time constant data, input level data such as range of aparameter value data; output level data such as boundary condition data;alarm condition data; and combinations thereof. The analysis producesone or more outputs to be utilized in Step 23. In a preferredembodiment, the data analyzed is selected from the group consisting of:cell sorting data such as spike sorting data; cellular signal modulationrates including modulation rates for a group of cells such as the groupused to produce the processed signals; a count of neural spikes; heartrhythm data; skin conductance data; respiration data; and combinationsthereof.

Step 23 includes the comparison of the one or more outputs of theanalysis of step 22 to one or more corresponding threshold values. Whenthe data analyzed is a set of the multicellular signals of thebiological interface apparatus of the present invention, the thresholdmay represent one or more of: a minimum modulation rate of one or morecells, a minimum number of cells with an acceptable modulation rate, orother multicellular signal parameter. In a preferred embodiment, oneoutput of the analysis of step 22 is a measurement of patientconsciousness and the threshold of step 23 is a minimum level ofconsciousness. If one or more comparisons to the associated one or morethresholds results in the threshold not being met, the systemconfiguration plan is modified, and the patient training routine returnsto step 20. In an alternative, at least one threshold value is set toforce at least one modification of the system configuration plan, suchas a threshold that cannot be met and is adjusted after the initialcomparison of step 23 to a feasible level.

The modification to the system configuration plan may be automaticallymade by the system, manually accomplished by an operator, or both. Themodification may require input from an operator, or multiple operators,and may invoke an integral permission routine of the system, as has beendescribed in detail hereabove. The modification may create a change inthe order of the steps of the first configuration plan. The modificationmay involve adding or deleting a step. The modification may result inthe patient training routine to increase or decrease in time.

If the comparison of the one or more outputs of step 22 successfullycompares to the one or more corresponding thresholds of step 23, step 24is performed wherein a transfer function is generated to apply to themulticellular signals detected by the sensor of the present inventionand produce the processed signals. Next sequential step 25 includesproviding the patient with control of one or more controlled devices.The patient performs one or more tasks with the one or more controlleddevices, and the performance of the patient control is measured. In apreferred embodiment, the measured performance is an error measurementof actual versus intended control. Performance data can be gathered withone or more sensors as well as one or more recording devices such as avideo recorder and/or or a digital camera. Image processing techniquescan be used to characterize the patient control of the controlleddevice. The characterization can be compared to a predetermined target,or it can be compared to a separate device movement pattern that thepatient tries to mimic with the one or more controlled devices.

Next sequential step 26 includes comparing the measured performance ofstep 25 with one or more associated threshold values, such as thethreshold values that can be modified by an operator of the system. Ifthe measured performance is below the associated threshold value orvalues, the system configuration plan is modified and the nextsequential step is initial step 20. If the measured performance is at orabove the associated threshold value or values, the next sequential step27 is performed. Step 27 includes building a transfer function, similaror dissimilar to the transfer function of step 24, the step 27 transferfunction used by the system to produce the processed signals of thepresent invention. The next sequential step 28 includes initiatingpatient control of one or more controlled devices of the presentinvention. These controlled devices may be the same as, similar to, ordifferent from the controlled devices of step 25.

Step 21 includes the building of a transfer function that is used tobuild a representation of the processed signals. The representation ofthe processed signal is a precursor to the processed signals used tocontrol the controlled device. The representation of the processedsignals may temporarily control the controlled device, a surrogate ofthe controlled device, or another device. In order to produce theprocessed signals, the processing unit includes a transfer function thatis applied to the multicellular signals. The transfer function includesand/or is based upon one or more system configuration parameters thatare generated and/or modified by the patient training routine. Therepresentation of the processed signal is also produced with a transferfunction that is applied to the multicellular signals, such as atransfer function that has parameters determined based on the temporalcorrelation of the first set of multicellular signals and the first setof states of the time varying stimulus. In an alternative, preferredembodiment, the representation of processed signals is modified with abias toward a time varying stimulus that acts as a target for thepatient's imagined movement. This improved control signal can be used asa motivator to the patient, and preferably has its improvement biasdecrease as patient control performance increases.

Step 22 includes the patient training routine providing a set of statesof a time varying stimulus and the representation of the processedsignal whose transfer function is created in Step 21. While the patientreceives, such as through viewing a visual display, listening to anaudio signal, and/or feeling a tactile transducer, both the set ofstates of the time varying stimulus as well as the patient controlledfeedback produced by the representation of processed signals, a next setof multicellular signals are recorded and stored. This next set is alsocorrelated to the set of states of the time varying stimulus, such as atemporal correlation and/or other correlation described hereabove. Therepresentation of the processed signal and/or the time varying stimulus,can be presented via the controlled device, a controlled devicesurrogate, or another device. The controlled device surrogate can beconfigured to be more complex than the intended controlled device, suchthat the patient is training with a more complicated device to improveeventual controlled device control. The surrogate device may have one ormore differences, such as a larger value of one or more of: degrees offreedom; resolution; modes; discrete states; functions; boundaryconditions; and combinations thereof. The boundary conditions of thesurrogate can differ in one or more of: maximum distance; maximumvelocity; maximum acceleration; maximum force; maximum torque; rotation;position; and combinations thereof.

The representation of the processed signals may be provided in a formsimilar to the time varying stimulus, or in a different form. In apreferred embodiment, the time varying stimulus is provided as an objecton a visual display, and the representation of processed signals is themotion of a mechanical object such as a prosthetic limb. Both the timevarying stimulus and the representation of processed signals can beprovided in multiple forms selected from: visual; tactile; auditory;olfactory; gustatory; and electrical stimulation such as corticalstimulation. Both the time varying stimulus and/or the representation ofprocessed signals can be provided as: moving object on screen; movingmechanical device such as a mechanical limb or wheelchair; moving partof patient's body such as via an exoskeleton device or FES device;changing audible signal such as a multi-frequency signal; andcombinations thereof.

Referring back to FIG. 6, step 22 also includes the measuring of theperformance of the representation of the processed signal as compared tothe time varying stimulus. In a preferred embodiment, both the timevarying stimulus and the representation of processed signals arepresented as an object on a computer screen, and the performance isbased on the ability of the patient to track the time varying stimulusobject with the patient controlled object controlled by therepresentation of the processed signals. A performance measure value isdetermined and this value is compared to a predetermined successthreshold value. If the performance measure value is at or above thesuccess threshold value, the next step to be followed is Step 23 inwhich the patient training routine is completed and the current transferfunction is subsequently used produce the processed signals to controlthe controlled device. If the performance measure value is below thesuccess threshold value, the next step to be followed is a repeat ofstep 21 and its subsequent steps. In a preferred embodiment, the successthreshold value is a system configuration parameter that is adjustablesuch as via a remote operator in which the permission routine is invokedto complete the change.

As stated above, if the performance meets or exceeds the threshold, thepatient training routine proceeds to Step 23 wherein the processing unitutilizes the transfer function determined in the patient trainingroutine to convert the multicellular signals received from the sensor ofthe present invention, and produces the processed signals to betransmitted to the controlled devices. In a preferred embodiment, athird set of states of time varying stimulus and a second representationof processed signals are used to create the transfer function. Thesecond representation of processed signals is based on a second set ofmulticellular signal data previously recorded, or a combination of thefirst and second sets of multicellular signal data. In another preferredembodiment, the patient training routine must be performed at least onetime in the use of the system, such as prior to the patient receivingfull control of the controlled device. In an alternative embodiment, thepatient training routine must be performed at least two times in the useof the system. In another preferred embodiment, the patient trainingroutine must be successfully completed, such as when a performanceparameter meets or exceeds a success threshold value, prior to thepatient receiving full control of the controlled device. Full control ofa controlled device is described in greater detail in reference to FIG.3 herebelow.

In another preferred embodiment, the system of the present inventionincludes two controlled devices, and the patient training routineprovides different feedback to the patient during the routine, such asdifferent time varying stimulus or other feedback. Alternatively oradditionally, the system may include a separate patient training routinefor each controlled device. For the multiple controlled devices, a firstset of states for a time varying stimulus will be provided to develop atransfer function for the first controlled device, and a second set ofstates for a time varying stimulus will be provided to develop atransfer function for the second controlled device. In a preferredembodiment, the first controlled device is a prosthetic or exoskeletondriven arm, and the second controlled device is a prosthetic orexoskeleton driven leg. In another preferred embodiment, the firstcontrolled device is a prosthetic or exoskeleton driven arm, and thesecond controlled device is a vehicle such as a wheelchair.

As stated above, the patient training routine can be used to generateone or more system configuration parameters used by the processing unitto develop a transfer function to produce processed signals. Theselection of cells for processing as well as criteria for selectingcells may be generated. A signal processing parameter can be generatedsuch as a coefficient modifying one or more of the following:amplification, filtering, sorting, conditioning, translating,interpreting, encoding, decoding, combining, extracting, sampling,multiplexing, analog to digital converting, digital to analogconverting, mathematically transforming; and combinations thereof. Acontrol signal transfer function parameter, such as a coefficient value;algorithm; methodology; mathematical equation; and combinations of thosemay be generation. A calibration parameter such as calibration frequencyand/or a controlled device parameter such as a controlled deviceparameter boundary limit may be generated. Other system configurationparameters that can be generated by the patient training routine includebut are not limited to: acceptable frequency range of cellular activity;selection of electrodes to include; selection of cellular signals toinclude; type of frequency analysis such as power spectral density;instruction information to patient such as imagined movement type orother imagined movement instruction; type, mode or configuration offeedback during provision of processed signal to patient; calibrationparameter such as calibration duration and calibration frequency;controlled device parameter such as controlled device mode; alarm oralert threshold; success threshold; and combinations thereof.

In another preferred embodiment, the patient training routine of thepresent invention adapts over time. Each time the patient trainingroutine is invoked, a patient training event, one or more changes may bemade for the next patient training event. A change may be caused by ameasurement of performance, such as controlled device controlperformance. A control at or above a threshold, measured as has beendescribed in detail hereabove, may result in a subsequent patienttraining routine of a shorter duration. Alternatively, performance belowa similar threshold may result in a longer patient training routine,and/or a modified patient training routine. The patient training routinemay adapt based on a multicellular signal change, such as the death ofone or more cells previously providing cellular signals. The patienttraining routine may adapt due to a change in a patient parameter, suchas a change due to a change in patience consciousness level. In thecircumstance wherein patience consciousness falls below a threshold, apatient training routine may adapt within the routine itself—such as torepeat a step, or delay a step until consciousness is at a higher level.Patient consciousness may be measured using the multicellular signals ofthe sensor of the present invention, or another sensor of the systemsuch as an EEG or LFP sensor.

In another preferred embodiment, the patient training routineautomatically adapts, such as by being triggered by a system-monitoredparameter crossing a threshold. Alternatively, the routine may adaptbased on an operator input. Routines may adapt within a single patienttraining event, or between patient training events. Routines may adaptbased on a measure of performance in a previous patient training routineevent, or based on a comparative difference between two patient trainingevents.

Numerous methods are provided in the multiple embodiments of thedisclosed invention. A preferred method embodiment includes providing anautomated patient training routine for a biological interface apparatusthat provides a visual representation of a human figure to the patient.The visual representation includes multiple body movements that areprovided such that the patient can imagine a similar movement. Thebiological interface system is for collecting multicellular signalsemanating from one or more living cells of a patient and fortransmitting processed signals to control a device. The biologicalinterface system comprises: a sensor for detecting the multicellularsignals, the sensor comprising a plurality of electrodes to allow fordetection of the multicellular signals; a processing unit for receivingthe multicellular signals from the sensor, for processing themulticellular signals to produce processed signals, and for transmittingthe processed signals; a controlled device for receiving the processedsignals; and a patient training routine for generating one or moresystem configuration parameters.

It should be understood that numerous other configurations of thesystems, devices and methods described herein could be employed withoutdeparting from the spirit or scope of this application. It should beunderstood that the system includes multiple functional components, suchas a sensor for detecting multicellular signals, a processing unit forprocessing the multicellular signals to produce processed signals, andthe controlled device that is controlled by the processed signals.Different from the logical components are physical or discretecomponents, which may include a portion of a logical component, anentire logical component and combinations of portions of logicalcomponents and entire logical components. These discrete components maycommunicate or transfer information to or from each other, orcommunicate with devices outside the system. In each system, physicalwires, such as electrical wires or optical fibers, can be used totransfer information between discrete components, or wirelesscommunication means can be utilized. Each physical cable can bepermanently attached to a discrete component, or can include attachmentmeans to allow attachment and potentially allow, but not necessarilypermit, detachment. Physical cables can be permanently attached at oneend, and include attachment means at the other.

The sensors of the systems of this application can take various forms,including multiple discrete component forms, such as multiplepenetrating arrays that can be placed at different locations within thebody of a patient. The processing unit of the systems of thisapplication can also be contained in a single discrete component ormultiple discrete components, such as a system with one portion of theprocessing unit implanted in the patient, and a separate portion of theprocessing unit external to the body of the patient. The sensors andother system components may be utilized for short term applications,such as applications less than twenty four hours, sub-chronicapplications such as applications less than thirty days, and chronicapplications. Processing units may include various signal conditioningelements such as amplifiers, filters, signal multiplexing circuitry,signal transformation circuitry and numerous other signal processingelements. In a preferred embodiment, an integrated spike sortingfunction is included. The processing units performs various signalprocessing functions including but not limited to: amplification,filtering, sorting, conditioning, translating, interpreting, encoding,decoding, combining, extracting, sampling, multiplexing, analog todigital converting, digital to analog converting, mathematicallytransforming and/or otherwise processing cellular signals to generate acontrol signal for transmission to a controllable device. The processingunit utilizes numerous algorithms, mathematical methods and softwaretechniques to create the desired control signal. The processing unit mayutilize neural net software routines to map cellular signals intodesired device control signals. Individual cellular signals may beassigned to a specific use in the system. The specific use may bedetermined by having the patient attempt an imagined movement or otherimagined state. For most applications, it is preferred that that thecellular signals be under the voluntary control of the patient. Theprocessing unit may mathematically combine various cellular signals tocreate a processed signal for device control.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims. In addition,where this application has listed the steps of a method or procedure ina specific order, it may be possible, or even expedient in certaincircumstances, to change the order in which some steps are performed,and it is intended that the particular steps of the method or procedureclaim set forth herebelow not be construed as being order-specificunless such order specificity is expressly stated in the claim.

1. A biological interface system comprising: a sensor comprising aplurality of electrodes for detecting multicellular signals emanatingfrom one or more living cells of a patient; a processing unit configuredto receive the multicellular signals from the sensor, process themulticellular signals to produce a processed signal, and transmit theprocessed signal to a controlled device; the controlled device forreceiving the processed signal; and an integrated patient trainingroutine performed to generate one or more system configurationparameters used by the processing unit to produce the processed signal,the patient training routine comprising: a system configuration plancomprising a first configuration of steps to be performed; means forcollecting a first set of patient data, the first set of patient datacollected prior to patient control of the controlled device; means foranalyzing the first set of patient data and providing an output of theanalysis; and means for modifying the system configuration plan; whereinthe system configuration plan is modified when the output of theanalysis of the first set of patient data falls below a successthreshold value, and wherein the success threshold value is set torequire at least one modification of the configuration plan prior to thepatient controlling the controlled device.
 2. The system of claim 1,wherein the first set of patient data does not include data regardingcontrol of the controlled device.
 3. The system of claim 1, wherein thefirst configuration of steps includes a cell sorting algorithm to selecta set of cells for processing.
 4. The system of claim 3, wherein thecell sorting algorithm is a neuron spike sorting algorithm.
 5. Thesystem of claim 3, wherein the success threshold value is a minimumnumber of cells selected for processing.
 6. The system of claim 1,wherein the first configuration of steps includes a measurement andanalysis of one or more cellular signal modulation rates.
 7. The systemof claim 1, wherein the first configuration of steps includes ameasurement and analysis of neural signals.
 8. The system of claim 7,wherein the output of the analysis includes a quantification of neuralspikes and the threshold value is a minimum number of spikes.
 9. Thesystem of claim 7, wherein the output of the analysis includes acellular signal modulation rate quantification and the threshold valueis a minimum level for the quantification.
 10. The system of claim 7,wherein the output of the analysis includes a multicellular signalmodulation rate quantification and the threshold value is a minimumlevel for the quantification.
 11. The system of claim 1, wherein thefirst configuration of steps includes a measurement and analysis of oneor more patient physiologic parameters.
 12. The system of claim 11,wherein the patient physiologic parameter is selected from the groupconsisting of: EKG; respiration; blood glucose; temperature; bloodpressure; EEG; perspiration; and combinations thereof.
 13. The system ofclaim 1, wherein the means for collecting patient data includes thesensor.
 14. The system of claim 1, further comprising a second sensorand wherein the means for collecting patient data includes the secondsensor.
 15. The system of claim 14, wherein the second sensor isselected from the group consisting of: EKG sensor; respiration sensor;blood glucose sensor; temperature sensor; blood pressure and otherpressure sensors; EEG sensor; perspiration sensor; cellular signalactivity including neural activity sensor; skin conductance and otherimpedance sensor; strain gauge; light sensor; and combinations thereof.16. The system of claim 1, wherein the patient training routine includesproviding the patient with a time varying stimulus, and the first set ofpatient data is collected while the time varying stimulus is provided.17. The system of claim 16, wherein the time varying stimulus ismanipulated manually by an operator.
 18. The system of claim 16, whereinthe time varying stimulus is produced by the processing unit.
 19. Thesystem of claim 16, wherein the time varying stimulus is produced by aseparate device.
 20. The system of claim 16, wherein the threshold valueis a measure of a patient response to the time varying stimulus.
 21. Thesystem of claim 1, further comprising a time varying stimulus producingelement.
 22. The system of claim 21, wherein the time varying stimulusproducing element is selected from the group consisting of: a display; atouch screen display; an audio transducer; a speaker; a tactiletransducer; an electrical stimulator; an electrode array; an olfactorytransducer; a gustatory transducer; and combinations thereof.
 23. Thesystem of claim 21, wherein the time varying stimulus provided to thepatient is a continuous or semi-continuous motion of an object.
 24. Thesystem of claim 23, wherein the object moves on a visual display. 25.The system of claim 23, wherein the object is a mechanical object movingin physical space.
 26. The system of claim 23, wherein the object is apart of the patient's body moving in space.
 27. The system of claim 21,wherein the time varying stimulus provides a fixed position of an objectfor a limited time.
 28. The system of claim 27, wherein the object is ona visual display.
 29. The system of claim 27, wherein the limited timeis less than one second.
 30. The system of claim 21, wherein the timevarying stimulus provides one or more flashes of light.
 31. The systemof claim 1, further comprising an internal memory storage element,wherein the first set of patient data is stored in the memory storageelement.
 32. The system of claim 31, wherein the storage element isintegral to a component of the system.
 33. The system of claim 32,wherein the component of the system is configured to be locatedproximate the patient.
 34. The system of claim 32, wherein the componentof the system is configured to be located at a site remote from thepatient.
 35. The system of claim 1, wherein the first set of patientdata includes neural data of the patient.
 36. The system of claim 35,wherein the neural data includes data from neurons of the patient'sbrain.
 37. The system of claim 36, wherein the neural data includes datafrom neurons of the motor cortex of the patient's brain.
 38. The systemof claim 35, wherein the neural data includes EEG or LFP data.
 39. Thesystem of claim 1, wherein the first set of data includes patientphysiologic data.
 40. The system of claim 39, wherein the physiologicdata is selected from the group consisting of: EKG; respiration; bloodglucose; temperature; blood pressure; EEG; perspiration; cellular signalactivity including neural activity; skin conductance; and combinationsthereof.
 41. The system of claim 1, wherein the system configurationplan is modified automatically.
 42. The system of claim 1, wherein thesystem configuration plan is modified manually by an operator of thesystem.
 43. The system of claim 1, wherein the system configuration planmodification includes a change to an order of the first configuration ofsteps.
 44. The system of claim 1, wherein the system configuration planmodification includes an additional step added to the firstconfiguration of steps.
 45. The system of claim 1, wherein the systemconfiguration plan modification includes the elimination of a step fromthe first configuration of steps.
 46. The system of claim 1, wherein thesystem configuration plan modification increases a time required tocomplete the system configuration plan.
 47. The system of claim 1,wherein the system configuration plan modification decreases a timerequired to complete the system configuration plan.
 48. The system ofclaim 1, wherein the system configuration plan modification requiresinput from an operator of the system.
 49. The system of claim 48,wherein the system configuration plan modification further requiresinput from a second operator of the system.
 50. The system of claim 1,wherein the system configuration plan modification requires analysis ofcontrolled device data that does not include data of the patientcontrolling the controlled device.
 51. The system of claim 50, whereinthe controlled device data is selected from the group consisting of:time constant data; input level data; range of value data; output leveldata; boundary condition data; alarm condition data; and combinationsthereof.
 52. The system of claim 1, further comprising an integralpermission routine, and wherein the system configuration planmodification invokes the permission routine.
 53. The system of claim 1,wherein the output of the analysis includes multiple values.
 54. Thesystem of claim 53, wherein at least two multiple values are compared tothe threshold value.
 55. The system of claim 54, wherein the at leasttwo multiple values are compared to different threshold values.
 56. Thesystem of claim 1, wherein the first set of patient data is a set of themulticellular signals received by the processing unit from the sensor.57. The system of claim 56, wherein the success threshold value is aminimum modulation rate level.
 58. The system of claim 57, wherein theminimum modulation rate level is a minimum modulation rate of one ormore cells.
 59. The system of claim 57, wherein the minimum modulationrate level is a minimum modulation rate of a number of cells used forproducing the processed signal.
 60. The system of claim 56, wherein thethreshold value is a minimum number of cells applicable to a transferfunction to produce the processed signal.
 61. The system of claim 1,wherein the success threshold value is a level of patient consciousness.62. The system of claim 1, further comprising means for analyzingcontrolled device performance.
 63. The system of claim 62, wherein themeans for analyzing controlled device performance includes one or moresensors in proximity to the controlled device.
 64. The system of claim62, wherein the analysis of controlled device performance includes anerror measurement of controlled device actual control versus controlleddevice intended control.
 65. The system of claim 64, wherein thecontrolled device actual control is compared to the controlled deviceintended control.
 66. The system of claim 1, wherein the patienttraining routine provides a visual representation of a human figure tothe patient, the representation including multiple human body movementsprovided for the patient to imagine the movement.
 67. The system ofclaim 66, wherein the first set of patient data includes multicellularsignals generated while the patient imagines the movement.
 68. Thesystem of claim 66, further comprising audible information providedcoincident with the visual representation.
 69. The system of claim 68,wherein the audible information includes spoken words.
 70. The system ofclaim 1, wherein the patient training routine comprises an integratedsoftware module embedded in the system.
 71. The system of claim 1,wherein the patient training routine comprises a set of steps.
 72. Thesystem of claim 71, wherein at least one step is advanced to thesubsequent step based on the completion of one or more patient involvedevents.
 73. The system of claim 72, wherein the patient involved eventis an activation of an input device by the patient.
 74. The system ofclaim 73, wherein the input device is selected from the group consistingof: chin joystick; eyebrow EMG switch; EEG activated switch; eye trackerhead tracker; neck movement switch; shoulder movement switch;sip-and-puff joystick controller; speech recognition switch; tongueswitch; and combinations thereof.
 75. The system of claim 1, wherein atleast one system configuration parameter is confirmed for modificationby an operator utilizing a permission routine of the system.
 76. Thesystem of claim 75, wherein the permission routine requires an operatorto utilize one or more of: a password; a user ID; a specific Internet IPaddress; a mechanical key; an electronic key; and an electromechanicalkey.
 77. The system of claim 1, further comprising a patient inputdevice for performing a function selected from the group consisting of:performing a selection; confirming a command; confirming a modificationof a system parameter; modifying the state of the system; performing asystem reset; and combinations thereof.
 78. The system of claim 77,wherein the parameter is modified utilizing a device selected from thegroup consisting of: chin joystick; eyebrow EMG switch; EEG activatedswitch; eye tracker; head tracker; neck movement switch; shouldermovement switch; sip-and-puff joystick controller; speech recognitionswitch; tongue switch; and combinations thereof.
 79. The system of claim1, wherein the system configuration parameters include the selection ofcells whose signals are processed by the processing unit.
 80. The systemof claim 1, wherein the system configuration parameters include one ormore criteria used to select cells whose signals are to be processed bythe processing unit.
 81. The system of claim 1, wherein the systemconfiguration parameters include a signal processing parameter.
 82. Thesystem of claim 81, wherein the signal processing parameter is acoefficient of a signal processing function selected from the groupconsisting of: amplification; filtering; sorting; conditioning;translating; interpreting; encoding; decoding; combining; extracting;sampling; multiplexing; analog to digital converting; digital to analogconverting; mathematically transforming; and combinations thereof. 83.The system of claim 1, wherein the system configuration parametersinclude a control signal transfer function parameter.
 84. The system ofclaim 83, wherein the transfer function parameter is a transfer functioncoefficient.
 85. The system of claim 83, wherein the transfer functionparameter is the selection of one or more of: algorithm; methodology;mathematical equation; and combinations thereof.
 86. The system of claim1, wherein the system configuration parameters include a calibrationparameter.
 87. The system of claim 86, wherein the calibration parameteris a calibration frequency.
 88. The system of claim 1, wherein thesystem configuration parameters include a controlled device parameter.89. The system of claim 88, wherein the controlled device parameter is aparameter determining a boundary limit of a controlled device parameter.90. The system of claim 1, wherein a system configuration parameter isselected from the group consisting of: acceptable frequency range ofcellular activity; cellular signal amplitude threshold value; selectionof electrodes to include; selection of cellular signals to include; typeof frequency analysis; power spectral density; instruction informationto patient; imagined movement type; imagined movement instruction; type,mode or configuration of feedback during provision of processed signalto patient; calibration parameter; calibration duration; calibrationfrequency; controlled device parameter; controlled device mode; alarm oralert threshold value; success threshold value; and combinationsthereof.
 91. The system of claim 1, wherein a system configurationparameter is stored within at least one discrete component of thesystem.
 92. The system of claim 1, wherein a system configurationparameter is a spike sorting parameter.
 93. The system of claim 92,wherein the spike sorting parameter is an amplitude threshold parameter.94. The system of claim 1, wherein a system configuration parameter is asignal processing parameter.
 95. The system of claim 94, wherein thesignal processing parameter is selected from the group consisting of:sampling rate by signal; sampling rate by group of signals;amplification by signal; amplification by group of signals; filterparameter by signal; filter parameter by group of signals; sortingvariable; conditioning variable; translating variable; interpretingvariable; encoding variable; decoding variable; extracting variable;mathematical transformation variable; signal to noise ratio variable;frequency of signal variable; amplitude of signal variable; neuronfiring rate variable; standard deviation in neuron firing rate variable;modulation of neuron firing rate variable; and combinations thereof. 96.The system of claim 1, wherein a system configuration parameter is asignal selection parameter.
 97. The system of claim 96, wherein thesignal selection parameter is selected from the group consisting of:electrode selection variable; cellular signal selection variable; neuronspike selection variable; electrocorticogram signal selection variable;local field potential selection variable; electroencephalogram signalselection variable; and combinations thereof.
 98. The system of claim 1,wherein a system configuration parameter is a controlled deviceparameter.
 99. The system of claim 98, wherein the controlled deviceparameter is selected from the group consisting of: allowed devices thatthe patient can control; unique ID for device; a handshaking protocol;parameter indicating partial control of a multi-function device;movement parameter of device; a position, velocity, acceleration,torque, direction and/or momentum variable of a device; a maximumvelocity parameter; a power parameter; a therapeutic device parameter;dose amount; time for start of dose; rate of dose; duty cycle of dose;amount of energy; stimulation energy; mechanical time constant variable;electrical time constant variable; and combinations thereof.
 100. Thesystem of claim 1, wherein one or more system configuration parametersare selected from the group consisting of: a list of permissions forspecific operator or operator types; operator usemames; operatorpasswords; on or off variables; system reset parameters; maximum on timeof system parameters; and allowable times of day for system use by thepatient.
 101. The system of claim 1, wherein a system configurationparameter is a calibration parameter.
 102. The system of claim 101,wherein the calibration parameter is selected from the group consistingof: electrode selection; cellular signal selection; neuron spikeselection; electrocorticogram signal selection; local field potentialsignal selection; electroencephalogram signal selection; sampling rateby signal; sampling rate by group of signals; amplification by signal;amplification by group of signals; filter parameters by signal; filterparameters by group of signals; patient activity during calibration;target number of signals required; patient disease state; patientcondition; patient age and other patient parameters; and combinationsthereof.
 103. The system of claim 1, wherein a system configurationparameter is a system performance criteria.
 104. The system of claim103, wherein the system performance criteria is selected from the groupconsisting of: target number of signals required; patient disease state;patient condition; patient age and other patient parameters.
 105. Thesystem of claim 1, wherein one or more system configuration parametersis selected from the group consisting of: algorithm selection parameter;group of mathematical algorithms parameter; information upload command;information download command; alarm, warning or alert parameter;criteria to determine adequate performance of system; failure thresholdparameter; and combinations thereof.
 106. A method comprising: detectingmulticellular signals emanating from one or more living cells of apatient using a sensor comprising a plurality of electrodes processingunit receiving the multicellular signals from the sensor processing themulticellular signals to produce a processed signal transmitting theprocessed signal to a controlled device the controlled device receivingthe processed signal, and performing an integrated patient trainingroutine to generate one or more system configuration parameters used bythe processed unit to produce the processed signal, wherein theintegrated patient training routine comprises: performing a firstconfiguration of steps defined by a system configuration plan theprocessing unit collecting a first set of patient data, the first set ofpatient data collected prior to patient control of the controlled devicethe processing unit analyzing the first set of patient data andproviding an output of the analysis and modifying the systemconfiguration plan when the output of the analysis of the first set ofpatient data falls below a success threshold value, wherein the successthreshold value is set to require at least one modification of theconfiguration plan prior to the patient controlling the controlleddevice.
 107. The method of claim 106 wherein the first set of patientdata does not include data regarding control of the controlled device.108. The method of claim 106 wherein the first configuration of stepsincludes a cell sorting algorithm to select a set of cells forprocessing.
 109. The method of claim 108 wherein the cell sortingalgorithm is a neuron spike sorting algorithm.
 110. The method of claim106 further comprising providing the patient with a time varyingstimulus, wherein the first set of patient data is collected while thetime varying stimulus is provided.
 111. The method of claim 110 whereinthe time varying stimulus is manipulated manually by an operator. 112.The method of claim 110 wherein the threshold value is a measure of apatient response to the time varying stimulus.
 113. The method of claim110 wherein the time varying stimulus is provided to the patient by atime varying stimulus producing element.
 114. The method of claim 113wherein the time varying stimulus producing element is selected from thegroup consisting of: a display; a touch screen display; an audiotransducer; a speaker; a tactile transducer; an electrical stimulator;an electrode array; an olfactory transducer; a gustatory transducer; andcombinations thereof.
 115. The method of claim 113 wherein the timevarying stimulus provided to the patient is a continuous orsemi-continuous motion of an object.
 116. The method of claim 115wherein the object moves on a visual display.
 117. The method of claim115 wherein the object is a mechanical object moving in physical space.118. The method of claim 106 wherein the first set of patient dataincludes neural data of the patient.
 119. The method of claim 118wherein the neural data includes data from neurons of the patient'sbrain.
 120. The method of claim 119 wherein the neural data includesdata from neurons of the motor cortex of the patient's brain.
 121. Themethod of claim 118 wherein the neural data includes EEG or LFP data.122. The method of claim 106 wherein modifying the system configurationplan is done automatically.
 123. The method of claim 106 whereinmodifying the system configuration plan includes a change to an order ofthe first configuration of steps.
 124. The method of claim 106 whereinmodifying the system configuration plan requires analysis of controlleddevice data that does not include data of the patient controlling thecontrolled device.